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出境医 / 临床实验 / Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.

Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.

Study Description
Brief Summary:
This study investigated the effect of dexmedetomidine in obese patients undergoing bariatric surgery.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Glucose Intolerance Insulin Resistance Drug: Dexmedetomidine Drug: 0.9% Sodium-chloride Drug: Fentanyl Drug: Morphine Sulfate Phase 4

Detailed Description:
A prospective, double-blind, randomized controlled trial was performed. Consenting obese adult patients with impaired glucose tolerance, undergoing bariatric surgery, were randomized, by a computer, to receive placebo (0.9% Sodium-chloride) or dexmedetomidine 1 ug/kg bolus in 10 minutes followed by an infusion of 0.5 ug/kg/h until the end of surgery. Baseline HgbA1c, glucose, and insulin plasmatic levels were measured. Subsequently, glucose and insulin levels were taken every 2 hours during the first 12 hours from the onset of the drug infusion. Intraoperative fentanyl and postoperative morphine consumption, pain score, the occurrence of emesis, and postoperative sedation levels were recorded as secondary outcomes.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Blinded
Primary Purpose: Treatment
Official Title: Effect of Dexmedetomidine on Postoperative Glucose Levels and Insulin Secretion Patterns in Obese Patients With Impaired Glucose Tolerance.
Actual Study Start Date : September 27, 2012
Actual Primary Completion Date : July 25, 2013
Actual Study Completion Date : July 25, 2013
Arms and Interventions
Arm Intervention/treatment
Experimental: Dexmedetomidine
After anesthesia induction, patients who were randomized to the Dexmedetomidine group received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.
 Drug: Dexmedetomidine
A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
Other Name: Precedex

Drug: Fentanyl
Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Other Name: Sublimaze

Drug: Morphine Sulfate
Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
Other Name: Morphine
Placebo Comparator: 0.9% Sodium-chloride
After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.
 Drug: 0.9% Sodium-chloride
The same infusion rate used in the dexmedetomidine group.
Other Name: Normal saline

Drug: Fentanyl
Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Other Name: Sublimaze

Drug: Morphine Sulfate
Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
Other Name: Morphine
Outcome Measures
Primary Outcome Measures :
  1. Plasmatic Glucose Levels (mg/dl). [ Time Frame: Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine ]
    Change of baseline glucose levels within the first 12 postoperative hours.

  2. Plasmatic Insulin Levels (uU/ml). [ Time Frame: Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine ]
    Change of baseline insulin levels within the first 12 postoperative hours.


Secondary Outcome Measures :
  1. Fentanyl Consumption. [ Time Frame: Since the beginning of anesthesia until the end of it, an average of one hour and a half. ]
    Amount of fentanyl (ug/kg) intraoperatively administered.

  2. Amount (mg) of Morphine Consumed. [ Time Frame: At 24h postoperative hours. ]
    Morphine consumption in the first 24 postoperative hours.

  3. Pain Scores in the First 24 Postoperative Hours. [ Time Frame: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7). ]
    Visual analogue scale (VAS), provided by patients, ranging from 0 to 10 (0= no pain and 10= worst possible pain). We considered a pain score between 1-3, 4-6 and 7-10 as mild, moderate and severe pain, respectively.

  4. Sedation-agitation Scores in the First 12 Postoperative Hours. [ Time Frame: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6). ]
    Sedation-agitation scale (SAS), ranging from 1 to 7 (1=unarousable, 2=very sedated, 3=sedated, 4=calm and cooperative, 5=agitated, 6=very agitated and 7=dangerous agitation).

  5. Postoperative Nausea and Vomiting. [ Time Frame: Postoperative nausea and vomiting during the first 12 postoperative hours. ]
    Number of patients with postoperative nausea and vomiting in the first 12 postoperative hours.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obese patient (BMI>30)
  • American Society of Anesthesiologists grades II or III
  • Diagnosis of impaired glucose tolerance
  • Undergoing sleeve gastrectomy

Exclusion Criteria:

  • Baseline glucose > 200mg/dl
  • Diagnosis of Diabetes
  • Under corticosteroids treatment
  • Oral hypoglycemic medication within 7 days previous surgery
  • Use of insulin within 24h previous surgery
  • Allergy to any drug used in the study
Contacts and Locations

Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
Layout table for investigator information
Study Director: Mauricio Ibacache, MD, PhD Pontificia Universidad Catolica de Chile
Tracking Information
First Submitted Date  ICMJE December 30, 2018
First Posted Date  ICMJE January 18, 2019
Results First Submitted Date  ICMJE December 8, 2019
Results First Posted Date  ICMJE October 1, 2020
Last Update Posted Date October 1, 2020
Actual Study Start Date  ICMJE September 27, 2012
Actual Primary Completion Date July 25, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2020)
  • Plasmatic Glucose Levels (mg/dl). [ Time Frame: Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine ]
    Change of baseline glucose levels within the first 12 postoperative hours.
  • Plasmatic Insulin Levels (uU/ml). [ Time Frame: Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine ]
    Change of baseline insulin levels within the first 12 postoperative hours.
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • Change of baseline glucose levels within the first 12 postoperative hours. [ Time Frame: Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine ]
    Glucose levels (mg/dl).
  • Change of baseline insulin levels within the first 12 postoperative hours. [ Time Frame: Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine ]
    Insulin levels (uU/ml).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2020)
  • Fentanyl Consumption. [ Time Frame: Since the beginning of anesthesia until the end of it, an average of one hour and a half. ]
    Amount of fentanyl (ug/kg) intraoperatively administered.
  • Amount (mg) of Morphine Consumed. [ Time Frame: At 24h postoperative hours. ]
    Morphine consumption in the first 24 postoperative hours.
  • Pain Scores in the First 24 Postoperative Hours. [ Time Frame: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7). ]
    Visual analogue scale (VAS), provided by patients, ranging from 0 to 10 (0= no pain and 10= worst possible pain). We considered a pain score between 1-3, 4-6 and 7-10 as mild, moderate and severe pain, respectively.
  • Sedation-agitation Scores in the First 12 Postoperative Hours. [ Time Frame: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6). ]
    Sedation-agitation scale (SAS), ranging from 1 to 7 (1=unarousable, 2=very sedated, 3=sedated, 4=calm and cooperative, 5=agitated, 6=very agitated and 7=dangerous agitation).
  • Postoperative Nausea and Vomiting. [ Time Frame: Postoperative nausea and vomiting during the first 12 postoperative hours. ]
    Number of patients with postoperative nausea and vomiting in the first 12 postoperative hours.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • Fentanyl Consumption. [ Time Frame: Intraoperative period. ]
    Amount (ug) of fentanyl administered intraoperatively.
  • Morphine consumption in the first 24 postoperative hours. [ Time Frame: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7). ]
    Amount (mg) of morphine consumed.
  • Pain Scores in the First 24 Postoperative Hours. [ Time Frame: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7). ]
    Visual analogue pain scores ranging from 0 to 10 (0= no pain and 10= worst pain).
  • Postoperative sedation in the first 12 postoperative hours. [ Time Frame: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6). ]
    Sedation-agitation scale ranging from 1 to 7 (1=unarousable and 7=dangerous agitation).
  • Postoperative nausea and vomiting in the first 24 postoperative hours. [ Time Frame: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7). ]
    Postoperative nausea and vomiting.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.
Official Title  ICMJE Effect of Dexmedetomidine on Postoperative Glucose Levels and Insulin Secretion Patterns in Obese Patients With Impaired Glucose Tolerance.
Brief Summary This study investigated the effect of dexmedetomidine in obese patients undergoing bariatric surgery.
Detailed Description A prospective, double-blind, randomized controlled trial was performed. Consenting obese adult patients with impaired glucose tolerance, undergoing bariatric surgery, were randomized, by a computer, to receive placebo (0.9% Sodium-chloride) or dexmedetomidine 1 ug/kg bolus in 10 minutes followed by an infusion of 0.5 ug/kg/h until the end of surgery. Baseline HgbA1c, glucose, and insulin plasmatic levels were measured. Subsequently, glucose and insulin levels were taken every 2 hours during the first 12 hours from the onset of the drug infusion. Intraoperative fentanyl and postoperative morphine consumption, pain score, the occurrence of emesis, and postoperative sedation levels were recorded as secondary outcomes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective, randomized, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Blinded
Primary Purpose: Treatment
Condition  ICMJE
  • Bariatric Surgery Candidate
  • Glucose Intolerance
  • Insulin Resistance
Intervention  ICMJE
  • Drug: Dexmedetomidine
    A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
    Other Name: Precedex
  • Drug: 0.9% Sodium-chloride
    The same infusion rate used in the dexmedetomidine group.
    Other Name: Normal saline
  • Drug: Fentanyl
    Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
    Other Name: Sublimaze
  • Drug: Morphine Sulfate
    Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
    Other Name: Morphine
Study Arms  ICMJE
  • Experimental: Dexmedetomidine
    After anesthesia induction, patients who were randomized to the Dexmedetomidine group received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.
    Interventions:
    • Drug: Dexmedetomidine
    • Drug: Fentanyl
    • Drug: Morphine Sulfate
  • Placebo Comparator: 0.9% Sodium-chloride
    After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.
    Interventions:
    • Drug: 0.9% Sodium-chloride
    • Drug: Fentanyl
    • Drug: Morphine Sulfate
Publications * Not Provided

*   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: January 17, 2019) 		40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 25, 2013
Actual Primary Completion Date July 25, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Obese patient (BMI>30)
  • American Society of Anesthesiologists grades II or III
  • Diagnosis of impaired glucose tolerance
  • Undergoing sleeve gastrectomy

Exclusion Criteria:

  • Baseline glucose > 200mg/dl
  • Diagnosis of Diabetes
  • Under corticosteroids treatment
  • Oral hypoglycemic medication within 7 days previous surgery
  • Use of insulin within 24h previous surgery
  • Allergy to any drug used in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809182
Other Study ID Numbers  ICMJE Dexmedetomidine and glycemia.
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eduardo Vega, Pontificia Universidad Catolica de Chile
Study Sponsor  ICMJE Pontificia Universidad Catolica de Chile
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mauricio Ibacache, MD, PhD Pontificia Universidad Catolica de Chile
PRS Account Pontificia Universidad Catolica de Chile
Verification Date September 2020

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