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出境医 / 临床实验 / Anesthetics and Cerebral Oxygenation in LSG

Anesthetics and Cerebral Oxygenation in LSG

Study Description
Brief Summary:

Obesity is a global health issue that affects different organ systems and may cause severe health issues. Patients with a BMI > 40 kg/m2 or those with a BMI > 35 kg/m2 with accompanying comorbidities are candidates for weight loss surgeries, which are generally referred to as bariatric surgeries. Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric surgery procedure gaining increased popularity in the surgical treatment of morbid obesity. However, LSG requires a reverse-Trendelenburg position and prolonged pneumoperitoneum. Carbon dioxide pneumoperitoneum increases intracranial pressure (ICP) by increasing intra-abdominal pressure and by causing dilation of cerebral vessels through carbon dioxide reabsorption. Also, the reverse-Trendelenburg position decreases cardiac output and mean arterial pressure (MAP) by reducing cardiac venous return. A Near-infrared spectroscopy (NIRS) is a non-invasive technique and provides continuous monitoring of regional cerebral tissue oxygen saturation (rSO2).

Sevoflurane and propofol are widely used for the maintenance of general anesthesia during bariatric surgery. Sevoflurane is an efficacious halogenated inhalational anesthetic for bariatric surgery because of its rapid and consistent recovery and because it does not cause hemodynamic instability because of its low blood solubility. Moreover, it increases global CBF through a direct intrinsic cerebral vasodilatory action and, in addition, it might improve cerebral oxygenation by decreasing the cerebral metabolic rate of oxygen (CMRO2) (luxury perfusion). Propofol can also be a suitable option for the maintenance of anesthesia in bariatric surgery. Propofol is a short-acting intravenous anesthetic agent with a very good recovery profile, and its elimination half-life and duration of action do not change in obese individuals. However, it has been reported that propofol may significantly decrease CBF by both suppressing CMRO2 and through a direct vasoconstrictive action. The impact of propofol on global CBF is more salient than that on CMRO2, resulting in a decrease in rSO2. The aim of the present study was to test the hypothesis that rSO2 is better preserved with sevoflurane than propofol in morbidly obese patients who have undergone LSG.


Condition or disease Intervention/treatment Phase
Morbid Obesity Bariatric Surgery Candidate Anesthesia Drug: Inhalational anesthetic Drug: Intravenous anesthetic Phase 4

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Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: For the investigation, the patients were randomly assigned to two groups; the Inhalation group including those who received sevoflurane-remifentanil for the maintenance of anesthesia (n = 30) and the TIVA (total intravenous anesthesia) group including those who had propofol-remifentanil infusion for the maintenance of anesthesia (n = 30). The anesthesiologist caring for the patient was aware of the group assignments. The patients were blinded to the group assignments.
Masking: Single (Participant)
Masking Description: The patients were randomly assigned using opaque sealed envelopes to two groups; the Inhalation group including those who received sevoflurane-remifentanil for the maintenance of anesthesia (n = 30) and the TIVA (total intravenous anesthesia) group including those who had propofol-remifentanil infusion for the maintenance of anesthesia (n = 30). Randomization was performed according to a computer-generated randomization code, and a statement showing the patients' group was placed in sealed, numbered enveloped according to the results. Each patient drew an envelope and was enrolled in the study depending on the group written in the envelope. Randomization was performed by a physician who was not involved in the monitorization of the patients.
Primary Purpose: Supportive Care
Official Title: A Comparison of Cerebral Oximetry After Propofol-Based Total Intravenous Anesthesia and Sevoflurane Inhalation Anesthesia in Morbidly Obese Patients Undergoing LSG: a Prospective, Single-Blinded, Randomized, Parallel-Group Study.
Actual Study Start Date : January 20, 2019
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 1, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: The Inhalation Group
Sevoflurane (1 minimum alveolar concentration [MAC]) were used in the Inhalation group for the maintenance of anesthesia.
Drug: Inhalational anesthetic
Oxygen/air (fraction of inspired oxygen (FiO2) of 0.40), inspiratory fresh gas flow of 2 L/min), sevoflurane (1 minimum alveolar concentration [MAC]) and remifentanil IV infusion (0.1-0.25 mcg/kg of LBW/min) were used.Neuromuscular blockade was performed during the operation by rocuronium infusion (0.3-0.7 mg/kg of LBW/h), ensuring that PTC was zero.

Active Comparator: The TIVA (total intravenous anesthesia) Group
Propofol infusion (4-8 mg/kg of total body weight/h) were used in the TIVA group.
Drug: Intravenous anesthetic
Propofol infusion (4-8 mg/kg of total body weight/h), oxygen/air (FiO2 of 0.40; inspiratory fresh gas flow of 2 L/min) and remifentanil IV infusion (0.1-0.25 μg/kg of LBW/min) were used.Neuromuscular blockade was performed during the operation by rocuronium infusion (0.3-0.7 mg/kg of LBW/h), ensuring that PTC was zero.

Outcome Measures
Primary Outcome Measures :
  1. Cerebral oxygen saturation [ Time Frame: The rSO2 values of the patients were recorded from baseline untill 20 minutes after the extubation, up to 120 min. ]
    The rSO2 values of the patients were recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit. Measurements in the last 30 seconds of preoxygenation, performed for three minutes with 4 L/min oxygen (80%) pre-induction, were accepted as preoperative values.Cerebral oxygen desaturation was defined as a greater than 25% decrease in the rSO2 value compared to the preoperative value (decrease should be more than 20% if the preoperative value is <50) and maintenance of this situation for ≥15 seconds. In this case, the following algorithm was used. First of all, normotension of the patient was ensured (administration of vasopressors such as ephedrine, and/or infusion of isotonic fluids) and the patient's neck was checked. External factors causing arterial or venous obstruction were restored, if any. If no recovery was seen despite these steps, FiO2 was set at 100%.

  2. Arterial Blood Gas (ABG) analysis-pH [ Time Frame: The pH values of the patients were recorded after anesthesia induction until the patient was referred to the recovery unit, up to 120 min. ]
    The pH values of the patients were measured in the fifth minute post-induction with the patient in the neutral position, in the 30th minute post-insufflation in the reverse-Trendelenburg position of patient and post-extubation right before the patient was referred to the recovery unit.

  3. Arterial Blood Gas (ABG) analysis-Partial pressure of carbon dioxide [ Time Frame: The partial pressure of carbon dioxide values of the patients were recorded after anesthesia induction until the patient was referred to the recovery unit, up to 120 min. ]
    The partial pressure of carbon dioxide values of the patients were measured in the fifth minute post-induction with the patient in the neutral position, in the 30th minute post-insufflation in the reverse-Trendelenburg position of patient and post-extubation right before the patient was referred to the recovery unit.

  4. Arterial Blood Gas (ABG) analysis-Hemoglobin [ Time Frame: The hemoglobin values of the patients were recorded after anesthesia induction until the patient was referred to the recovery unit, up to 120 min. ]
    The hemoglobin values of the patients were measured in the fifth minute post-induction with the patient in the neutral position, in the 30th minute post-insufflation in the reverse-Trendelenburg position of patient and post-extubation right before the patient was referred to the recovery unit.


Secondary Outcome Measures :
  1. The heart rate (HR) measurement [ Time Frame: The heart rate was recorded from baseline until the patient was referred to the recovery unit, up to 120 min. ]
    The heart rate was recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit. HR values were allowed to fluctuate up to 20% of the preoperative values of the patients. For this purpose, the infusion rate of remifentanil was accordingly increased and decreased. Whenbradycardia (HR <45 beats/minute) continued for longer than three minutes, they were treated with IV 0.5 mg atropine.

  2. The oxygen saturation measurement [ Time Frame: The oxygen saturation was recorded from baseline until the patient was referred to the recovery unit, up to 120 min. ]
    The oxygen saturation was recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit.

  3. The mean arterial pressure measurement [ Time Frame: The mean arterial pressure was recorded from baseline until the patient was referred to the recovery unit, up to 120 min. ]
    The mean arterial pressure was recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit.

  4. The end-tidal carbon dioxide partial pressure measurement [ Time Frame: The end-tidal carbon dioxide partial pressure was recorded from baseline until the patient was referred to the recovery unit, up to 120 min. ]
    The end-tidal carbon dioxide partial pressure was recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit.

  5. The anesthesia time (min) [ Time Frame: The anesthesia time was recorded through study completion. ]
    The anesthesia time was defined as the length of time the patient was anesthetized.

  6. The reverse-Trendelenburg time (min) [ Time Frame: The reverse-Trendelenburg time was recorded through study completion. ]
    The reverse-Trendelenburg time was defined as the length of time the patient was in the reverse-Trendelenburg position.

  7. The pneumoperitoneum time (min) [ Time Frame: The pneumoperitoneum time was recorded through study completion. ]
    The pneumoperitoneum time was defined as the length of time the patient had pneumoperitoneum

  8. The recovery time (min) [ Time Frame: The recovery time was recorded at the end of the surgery untill the extubation. ]
    The recovery time was defined as the time from discontinuation of sevoflurane or propofol and remifentanil at the end of the surgery to the restoration of spontaneous breathing, opening of the eyes upon a verbal command, squeezing of the hand of the observer and extubation.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The American Society of Anaesthesiologists (ASA) physical status class II-III
  • BMI of ≥ 35 kg/m2
  • Patients were planning on undergoing an elective laparoscopic sleeve gastrectomy (LSG)

Exclusion Criteria:

  • Patients with preexisting cerebrovascular diseases, overt neurological signs, alcohol or psychoactive drug addiction
  • Uncontrolled diabetes or hypertension
  • Advanced organ failure
  • Preoperative peripheral oxygen saturation (SpO2) less than 96%
  • Hemoglobin <9 g/dL .
Contacts and Locations

Locations
Layout table for location information
Turkey
Ondokuz Mayis Universitesi
Samsun, Atakum, Turkey, 55139
Sponsors and Collaborators
Ondokuz Mayıs University
Investigators
Layout table for investigator information
Principal Investigator: CENGIZ KAYA, Assoc. Prof. Ondokuz Mayis University, School of Medicine, Department of Anesthesiology
Tracking Information
First Submitted Date  ICMJE May 7, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date July 22, 2020
Actual Study Start Date  ICMJE January 20, 2019
Actual Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Cerebral oxygen saturation [ Time Frame: The rSO2 values of the patients were recorded from baseline untill 20 minutes after the extubation, up to 120 min. ]
    The rSO2 values of the patients were recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit. Measurements in the last 30 seconds of preoxygenation, performed for three minutes with 4 L/min oxygen (80%) pre-induction, were accepted as preoperative values.Cerebral oxygen desaturation was defined as a greater than 25% decrease in the rSO2 value compared to the preoperative value (decrease should be more than 20% if the preoperative value is <50) and maintenance of this situation for ≥15 seconds. In this case, the following algorithm was used. First of all, normotension of the patient was ensured (administration of vasopressors such as ephedrine, and/or infusion of isotonic fluids) and the patient's neck was checked. External factors causing arterial or venous obstruction were restored, if any. If no recovery was seen despite these steps, FiO2 was set at 100%.
  • Arterial Blood Gas (ABG) analysis-pH [ Time Frame: The pH values of the patients were recorded after anesthesia induction until the patient was referred to the recovery unit, up to 120 min. ]
    The pH values of the patients were measured in the fifth minute post-induction with the patient in the neutral position, in the 30th minute post-insufflation in the reverse-Trendelenburg position of patient and post-extubation right before the patient was referred to the recovery unit.
  • Arterial Blood Gas (ABG) analysis-Partial pressure of carbon dioxide [ Time Frame: The partial pressure of carbon dioxide values of the patients were recorded after anesthesia induction until the patient was referred to the recovery unit, up to 120 min. ]
    The partial pressure of carbon dioxide values of the patients were measured in the fifth minute post-induction with the patient in the neutral position, in the 30th minute post-insufflation in the reverse-Trendelenburg position of patient and post-extubation right before the patient was referred to the recovery unit.
  • Arterial Blood Gas (ABG) analysis-Hemoglobin [ Time Frame: The hemoglobin values of the patients were recorded after anesthesia induction until the patient was referred to the recovery unit, up to 120 min. ]
    The hemoglobin values of the patients were measured in the fifth minute post-induction with the patient in the neutral position, in the 30th minute post-insufflation in the reverse-Trendelenburg position of patient and post-extubation right before the patient was referred to the recovery unit.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • The heart rate (HR) measurement [ Time Frame: The heart rate was recorded from baseline until the patient was referred to the recovery unit, up to 120 min. ]
    The heart rate was recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit. HR values were allowed to fluctuate up to 20% of the preoperative values of the patients. For this purpose, the infusion rate of remifentanil was accordingly increased and decreased. Whenbradycardia (HR <45 beats/minute) continued for longer than three minutes, they were treated with IV 0.5 mg atropine.
  • The oxygen saturation measurement [ Time Frame: The oxygen saturation was recorded from baseline until the patient was referred to the recovery unit, up to 120 min. ]
    The oxygen saturation was recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit.
  • The mean arterial pressure measurement [ Time Frame: The mean arterial pressure was recorded from baseline until the patient was referred to the recovery unit, up to 120 min. ]
    The mean arterial pressure was recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit.
  • The end-tidal carbon dioxide partial pressure measurement [ Time Frame: The end-tidal carbon dioxide partial pressure was recorded from baseline until the patient was referred to the recovery unit, up to 120 min. ]
    The end-tidal carbon dioxide partial pressure was recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit.
  • The anesthesia time (min) [ Time Frame: The anesthesia time was recorded through study completion. ]
    The anesthesia time was defined as the length of time the patient was anesthetized.
  • The reverse-Trendelenburg time (min) [ Time Frame: The reverse-Trendelenburg time was recorded through study completion. ]
    The reverse-Trendelenburg time was defined as the length of time the patient was in the reverse-Trendelenburg position.
  • The pneumoperitoneum time (min) [ Time Frame: The pneumoperitoneum time was recorded through study completion. ]
    The pneumoperitoneum time was defined as the length of time the patient had pneumoperitoneum
  • The recovery time (min) [ Time Frame: The recovery time was recorded at the end of the surgery untill the extubation. ]
    The recovery time was defined as the time from discontinuation of sevoflurane or propofol and remifentanil at the end of the surgery to the restoration of spontaneous breathing, opening of the eyes upon a verbal command, squeezing of the hand of the observer and extubation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anesthetics and Cerebral Oxygenation in LSG
Official Title  ICMJE A Comparison of Cerebral Oximetry After Propofol-Based Total Intravenous Anesthesia and Sevoflurane Inhalation Anesthesia in Morbidly Obese Patients Undergoing LSG: a Prospective, Single-Blinded, Randomized, Parallel-Group Study.
Brief Summary

Obesity is a global health issue that affects different organ systems and may cause severe health issues. Patients with a BMI > 40 kg/m2 or those with a BMI > 35 kg/m2 with accompanying comorbidities are candidates for weight loss surgeries, which are generally referred to as bariatric surgeries. Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric surgery procedure gaining increased popularity in the surgical treatment of morbid obesity. However, LSG requires a reverse-Trendelenburg position and prolonged pneumoperitoneum. Carbon dioxide pneumoperitoneum increases intracranial pressure (ICP) by increasing intra-abdominal pressure and by causing dilation of cerebral vessels through carbon dioxide reabsorption. Also, the reverse-Trendelenburg position decreases cardiac output and mean arterial pressure (MAP) by reducing cardiac venous return. A Near-infrared spectroscopy (NIRS) is a non-invasive technique and provides continuous monitoring of regional cerebral tissue oxygen saturation (rSO2).

Sevoflurane and propofol are widely used for the maintenance of general anesthesia during bariatric surgery. Sevoflurane is an efficacious halogenated inhalational anesthetic for bariatric surgery because of its rapid and consistent recovery and because it does not cause hemodynamic instability because of its low blood solubility. Moreover, it increases global CBF through a direct intrinsic cerebral vasodilatory action and, in addition, it might improve cerebral oxygenation by decreasing the cerebral metabolic rate of oxygen (CMRO2) (luxury perfusion). Propofol can also be a suitable option for the maintenance of anesthesia in bariatric surgery. Propofol is a short-acting intravenous anesthetic agent with a very good recovery profile, and its elimination half-life and duration of action do not change in obese individuals. However, it has been reported that propofol may significantly decrease CBF by both suppressing CMRO2 and through a direct vasoconstrictive action. The impact of propofol on global CBF is more salient than that on CMRO2, resulting in a decrease in rSO2. The aim of the present study was to test the hypothesis that rSO2 is better preserved with sevoflurane than propofol in morbidly obese patients who have undergone LSG.

Detailed Description

All patients were administered 300 mg of oral ranitidine the night before the surgery and 10 mg intravenous (IV) metoclopramide in combination with 150 mg ranitidine one hour before arrival to the operating room. Upon the arrival to the operating room, an electrocardiogram, noninvasive blood pressure, SpO2, rSO2 (INVOSTM 5100C oximeter; Covidien, Massachusetts, USA) and neuromuscular monitorization (TOF-WatchTM SX, Organon, Dublin, Ireland) were performed on the patients. Afterwards, preoxygenation was performed with 4 L/min oxygen (80%) for three minutes by using facemasks, and anesthesia was induced with an IV propofol injection (1.5-2.5 mg/kg of ideal body weight) and an IV bolus administration of remifentanil [1 mcg/kg of lean body weight (LBW)] for 30-60 s, and then switched to infusion at 0.25 mcg/kg of LBW/min. After the eyelid reflex disappeared, a neuromuscular blockade was performed using rocuronium (1.2 mg/kg of LBW), ensuring that the train-of-four count and the post-tetanic count (PTC) were both zero, and performed tracheal intubation. Mechanical ventilation was performed with a Draeger FabiusTM Plus anesthesia workstation (Draeger Medical, Lübeck, Germany), and volume-controlled mechanical ventilation was applied. Breathing gases (oxygen, carbon dioxide, sevoflurane) were measured using Draeger ScioTM gas measurement module (Draeger Medical, Lübeck, Germany). The tidal volume was set as 7-8 mL/kg of LBW, inspiratory: expiratory ratio as 1:2, positive end-expiratory pressure as 5-8 cmH2O, and the respiratory rate was determined to obtain an end-tidal carbon dioxide partial pressure (PETCO2) of 32-37 mmHg. These ventilator settings were not changed throughout the operation. Furthermore, after the induction of anesthesia, a radial arterial line was placed in all patients for the continuous measurement of mean arterial pressure and intermittent arterial blood gas analysis.

Oxygen/air (fraction of inspired oxygen (FiO2) of 0.40), inspiratory fresh gas flow of 2 L/min), sevoflurane (1 minimum alveolar concentration [MAC]) and remifentanil IV infusion (0.1-0.25 mcg/kg of LBW/min) were used in the Inhalation group for the maintenance of anesthesia. Propofol infusion (4-8 mg/kg of total body weight/h), oxygen/air (FiO2 of 0.40; inspiratory fresh gas flow of 2 L/min) and remifentanil IV infusion (0.1-0.25 μg/kg of LBW/min) were used in the TIVA group. Neuromuscular blockade was performed during the operation by rocuronium infusion (0.3-0.7 mg/kg of LBW/h), ensuring that PTC was zero. IV normal saline or lactated Ringer's solution at 5-7 mL/kg of LBW was also used for perioperative fluid maintenance. Nasopharyngeal temperature was monitored throughout the surgery, and the patient temperature (36-37°C) was ensured by using a forced-air warming system for the maintenance of intraoperative normothermia during the procedure.

After anesthesia induction, a neutral head position of the patients was preserved to prevent alteration of cerebral venous drainage. Carbon dioxide insufflation was performed with an electronic laparoflator using a closed Veress needle technique, and intra-abdominal pressure was automatically kept at the desired level (14-16 mmHg) during the surgery. After the insufflation of carbon dioxide, the patients were positioned in a 30° reverse-Trendelenburg and at a 10° right lateral position.

At the end of the surgery, the blockade was reversed by administering 4 mg/kg of adjusted body weight sugammadex with a PTC of 1-2. All patients were extubated in the beach chair position when fully awake. The patients were referred to the recovery unit and monitored for 50 minutes for complications. In cases where no complications were apparent, the recovery was evaluated using the modified Aldrete scoring system. Once the score was ≥9, the patients were taken to unit. For postoperative nausea and vomiting, 4-5 mg dexamethasone was used (except for diabetic patients on insulin) 90 min before anesthesia induction and 4-8 mg IV ondansetron 20-30 min before the end of the operation. For postoperative pain management, 1 g IV acetaminophen was administered 20 min after induction and 30 mg IV ketorolac 20 min before onset. Then, 1 g IV acetaminophen was administered every 6 h + 50 mg IV dexketoprofen every 8 h for the first 48 hours. In addition, morphine was administered using a patient-controlled analgesia delivery system (demand dose, 20 µg/kg of ideal body weight; lockout time, 6-10 min; 4 h limit, 80% of the total calculated dosage) for 48 h postoperatively.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
For the investigation, the patients were randomly assigned to two groups; the Inhalation group including those who received sevoflurane-remifentanil for the maintenance of anesthesia (n = 30) and the TIVA (total intravenous anesthesia) group including those who had propofol-remifentanil infusion for the maintenance of anesthesia (n = 30). The anesthesiologist caring for the patient was aware of the group assignments. The patients were blinded to the group assignments.
Masking: Single (Participant)
Masking Description:
The patients were randomly assigned using opaque sealed envelopes to two groups; the Inhalation group including those who received sevoflurane-remifentanil for the maintenance of anesthesia (n = 30) and the TIVA (total intravenous anesthesia) group including those who had propofol-remifentanil infusion for the maintenance of anesthesia (n = 30). Randomization was performed according to a computer-generated randomization code, and a statement showing the patients' group was placed in sealed, numbered enveloped according to the results. Each patient drew an envelope and was enrolled in the study depending on the group written in the envelope. Randomization was performed by a physician who was not involved in the monitorization of the patients.
Primary Purpose: Supportive Care
Condition  ICMJE
  • Morbid Obesity
  • Bariatric Surgery Candidate
  • Anesthesia
Intervention  ICMJE
  • Drug: Inhalational anesthetic
    Oxygen/air (fraction of inspired oxygen (FiO2) of 0.40), inspiratory fresh gas flow of 2 L/min), sevoflurane (1 minimum alveolar concentration [MAC]) and remifentanil IV infusion (0.1-0.25 mcg/kg of LBW/min) were used.Neuromuscular blockade was performed during the operation by rocuronium infusion (0.3-0.7 mg/kg of LBW/h), ensuring that PTC was zero.
  • Drug: Intravenous anesthetic
    Propofol infusion (4-8 mg/kg of total body weight/h), oxygen/air (FiO2 of 0.40; inspiratory fresh gas flow of 2 L/min) and remifentanil IV infusion (0.1-0.25 μg/kg of LBW/min) were used.Neuromuscular blockade was performed during the operation by rocuronium infusion (0.3-0.7 mg/kg of LBW/h), ensuring that PTC was zero.
Study Arms  ICMJE
  • Active Comparator: The Inhalation Group
    Sevoflurane (1 minimum alveolar concentration [MAC]) were used in the Inhalation group for the maintenance of anesthesia.
    Intervention: Drug: Inhalational anesthetic
  • Active Comparator: The TIVA (total intravenous anesthesia) Group
    Propofol infusion (4-8 mg/kg of total body weight/h) were used in the TIVA group.
    Intervention: Drug: Intravenous anesthetic
Publications *
  • Soleimanpour H, Safari S, Sanaie S, Nazari M, Alavian SM. Anesthetic Considerations in Patients Undergoing Bariatric Surgery: A Review Article. Anesth Pain Med. 2017 Jul 11;7(4):e57568. doi: 10.5812/aapm.57568. eCollection 2017 Aug. Review.
  • Schofield DL, Morton PG, Brokos C, Gruel R, Johannes S, McBride N, et al. Perioperative Assessment and Risk Stratification of the Obese Patient. Bariat Nurs Surg Pat 2011;6:201 - 206.
  • Himpens J, Dobbeleir J, Peeters G. Long-term results of laparoscopic sleeve gastrectomy for obesity. Ann Surg. 2010 Aug;252(2):319-24. doi: 10.1097/SLA.0b013e3181e90b31.
  • Yorulmaz IS, Demiraran Y, Salihoglu Z, Umutoglu T, Ozaydin I, Dogan S. Effect of PEEP, Zero PEEP and Intraabdominal Pressure Levels on Cerebral Oxygenation in the Morbidly Obese Undergoing Sleeve Gastrectomy. Bariatr Surg Pract P 2017;12:123 - 129.
  • Willeumier KC, Taylor DV, Amen DG. Elevated BMI is associated with decreased blood flow in the prefrontal cortex using SPECT imaging in healthy adults. Obesity (Silver Spring). 2011 May;19(5):1095-7. doi: 10.1038/oby.2011.16. Epub 2011 Feb 10.
  • Sollazzi L, Perilli V, Modesti C, Annetta MG, Ranieri R, Tacchino RM, Proietti R. Volatile anesthesia in bariatric surgery. Obes Surg. 2001 Oct;11(5):623-6.
  • Kaisti KK, Långsjö JW, Aalto S, Oikonen V, Sipilä H, Teräs M, Hinkka S, Metsähonkala L, Scheinin H. Effects of sevoflurane, propofol, and adjunct nitrous oxide on regional cerebral blood flow, oxygen consumption, and blood volume in humans. Anesthesiology. 2003 Sep;99(3):603-13.
  • Servin F, Farinotti R, Haberer JP, Desmonts JM. Propofol infusion for maintenance of anesthesia in morbidly obese patients receiving nitrous oxide. A clinical and pharmacokinetic study. Anesthesiology. 1993 Apr;78(4):657-65.
  • Engelhard K, Werner C. Inhalational or intravenous anesthetics for craniotomies? Pro inhalational. Curr Opin Anaesthesiol. 2006 Oct;19(5):504-8. Review.
  • Honca M, Honca T. Comparison of Propofol with Desflurane for Laparoscopic Sleeve Gastrectomy in Morbidly Obese patients: A Prospective Randomized Trial. Bariatr Surg Pract P 2017;12:49 - 54.
  • Reinsfelt B, Westerlind A, Ricksten SE. The effects of sevoflurane on cerebral blood flow autoregulation and flow-metabolism coupling during cardiopulmonary bypass. Acta Anaesthesiol Scand. 2011 Jan;55(1):118-23. doi: 10.1111/j.1399-6576.2010.02324.x. Epub 2010 Oct 7.
  • Dagal A, Lam AM. Cerebral autoregulation and anesthesia. Curr Opin Anaesthesiol. 2009 Oct;22(5):547-52. doi: 10.1097/ACO.0b013e32833020be. Review.
  • Klein KU, Schramm P, Glaser M, Reisch R, Tresch A, Werner C, Engelhard K. Intraoperative monitoring of cerebral microcirculation and oxygenation--a feasibility study using a novel photo-spectrometric laser-Doppler flowmetry. J Neurosurg Anesthesiol. 2010 Jan;22(1):38-45. doi: 10.1097/ANA.0b013e3181bea439.
  • Klein KU, Fukui K, Schramm P, Stadie A, Fischer G, Werner C, Oertel J, Engelhard K. Human cerebral microcirculation and oxygen saturation during propofol-induced reduction of bispectral index. Br J Anaesth. 2011 Nov;107(5):735-41. doi: 10.1093/bja/aer227. Epub 2011 Jul 31.
  • Jeong H, Jeong S, Lim HJ, Lee J, Yoo KY. Cerebral oxygen saturation measured by near-infrared spectroscopy and jugular venous bulb oxygen saturation during arthroscopic shoulder surgery in beach chair position under sevoflurane-nitrous oxide or propofol-remifentanil anesthesia. Anesthesiology. 2012 May;116(5):1047-56. doi: 10.1097/ALN.0b013e31825154d2.
  • Valencia L, Rodríguez-Pérez A, Kühlmorgen B, Santana RY. Does sevoflurane preserve regional cerebral oxygen saturation measured by near-infrared spectroscopy better than propofol? Ann Fr Anesth Reanim. 2014 Apr;33(4):e59-65. doi: 10.1016/j.annfar.2013.12.020. Epub 2014 Feb 24.
  • Ružman T, Šimurina T, Gulam D, Ružman N, Miškulin M. Sevoflurane preserves regional cerebral oxygen saturation better than propofol: Randomized controlled trial. J Clin Anesth. 2017 Feb;36:110-117. doi: 10.1016/j.jclinane.2016.10.010. Epub 2016 Dec 1.
  • Sen P, Izdes S, But A. Effects of sevoflurane and propofol anaesthesia on cerebral oxygenation during normocapnia and mild hypercapnia: a pilot study. Br J Anaesth. 2013 Feb;110(2):318-9. doi: 10.1093/bja/aes489.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2019)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1, 2019
Actual Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The American Society of Anaesthesiologists (ASA) physical status class II-III
  • BMI of ≥ 35 kg/m2
  • Patients were planning on undergoing an elective laparoscopic sleeve gastrectomy (LSG)

Exclusion Criteria:

  • Patients with preexisting cerebrovascular diseases, overt neurological signs, alcohol or psychoactive drug addiction
  • Uncontrolled diabetes or hypertension
  • Advanced organ failure
  • Preoperative peripheral oxygen saturation (SpO2) less than 96%
  • Hemoglobin <9 g/dL .
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03946657
Other Study ID Numbers  ICMJE B.30.2.ODM.0.20.08/27-230
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cengiz KAYA, Ondokuz Mayıs University
Study Sponsor  ICMJE Ondokuz Mayıs University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: CENGIZ KAYA, Assoc. Prof. Ondokuz Mayis University, School of Medicine, Department of Anesthesiology
PRS Account Ondokuz Mayıs University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP