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出境医 / 临床实验 / Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension

Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension

Study Description
Brief Summary:
Deliberate hypotension is used to provide bloodless field during endoscopic sinus surgery; however, hypotension might impair perfusion of vital organs. The aim of this work is to compare the impact of nitroglycerin and labetalol on peripheral perfusion when used for induction of deliberate hypotension

Condition or disease Intervention/treatment Phase
Tissue Perfusion Deliberate Hypotension Sinus Endoscopic Surgery Drug: Nitroglycerin Drug: Labetalol Phase 4

Detailed Description:
Hypotensive anesthesia is associated with the risk of reduced tissue perfusion. The usual target mean arterial pressure during deliberate hypotension is 50- 65 mmHg; however, the status of peripheral perfusion under this target is not well investigated. Nitroglycerin and Labetalol are commonly used drugs to achieve deliberate hypotension. Nitroglycerin is a direct vasodilator and its main action is through venodilation, while labetalol combines a selective α1 and non selective beta-adrenergic blocking activity. Both drugs were previously compared during deliberate hypotension with regard to surgical field quality and blood loss. No study to date compared the effects of both drugs on peripheral perfusion when used for induction of deliberate hypotension. The Peripheral Perfusion Index (PPI) is the ratio between pulsatile and non-pulsatile components of peripheral circulation. Measurement of PPI is based on analysis of the pulse oximetry signal. PPI showed increasing popularity as a non invasive monitor of peripheral perfusion. Serum lactate is another frequently used marker of global tissue perfusion.The aim of this study is to compare the influence of nitroglycerin and labetalol on tissue perfusion when used for induction of deliberate hypotension during FESS operations. Tissue perfusion will be evaluated using PPI and serum lactate as markers of peripheral and global tissue perfusion respectively.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension for Sinus Endoscopic Surgery.
Actual Study Start Date : January 19, 2019
Actual Primary Completion Date : May 25, 2019
Actual Study Completion Date : May 25, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: group N
Patients in this group will receive Nitroglycerin infusion for deliberate hypotension at a rate of 0.5-2 μg /kg/min .
 Drug: Nitroglycerin
Nitroglycerin is a direct vasodilator and its main action is through venodilation. Nitroglycerin will be diluted by adding 3 mL (3 mg) to 47 mL normal saline in a 50 mL syringe and will be infused after endotracheal intubation with a starting dose of 0.5 mL/Kg/ hr to have a starting dose of 0.5 μg/Kg/min. The rate of nitroglycerin infusion will be 0.5-2 μg /kg/min .The infusion rate will be finely adjusted to maintain MAP around 55-65mmHg or till reaching adequate surgical field {defined as surgical field score (SFS) <3}.
Active Comparator: group L
Patients in this group will receive Labetalol infusion for deliberate hypotension at a rate of be 0.5-2 mg/kg/h .
 Drug: Labetalol
Labetalol is an α and β - adrenergic receptors competitive antagonist. Labetalol will be diluted by adding 10 mL (50 mg) to 40 mL normal saline in a 50 mL syringe and will be infused after endotracheal intubation with a starting dose of 0.5 mL/Kg/ hr. The rate of Labetalol infusion will be 0.5-2 mg/kg/h.The infusion rate will be finely adjusted to maintain MAP around 55-65mmHg or till reaching adequate surgical field {defined as surgical field score (SFS) <3}.
Outcome Measures
Primary Outcome Measures :
  1. Peripheral perfusion index [ Time Frame: 4 hours ]
    Peripheral perfusion index will be used as a marker of peripheral perfusion.


Secondary Outcome Measures :
  1. Change in serum lactate concentration [ Time Frame: Immediately before induction of anesthesia and after 60 minutes post recovery. ]
    Serum lactate concentration will be used as a marker of global tissue perfusion.Two samples will be obtained.

  2. Total blood loss [ Time Frame: from beginning of surgery till the end of the procedure ]
    Total blood loss will be measured from the suction device and gauzes that will be used to dry the surgical field.

  3. Surgical field score (SFS) [ Time Frame: from beginning of surgery till the end of the procedure. ]

    SFS ranges from 0 to 5 as follows: 0: No bleeding, 1: Slight bleeding-no suctioning of blood required, 2: Slight bleeding-occasional suctioning required. Surgical field not threatened. 3: Slight bleeding-frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed, 4: Moderate bleeding-frequent suctioning required. Bleeding threatens surgical field directly after suction is removed, 5: Severe bleeding-constant suctioning required. Bleeding appears faster that can be removed by suction. Surgical field severely threatened and surgery not possible.

    Adequate surgical field is defined as SFS <3


  4. Mean arterial blood pressure [ Time Frame: 4 hours ]
    Target mean arterial pressure during deliberate hypotension will be 55-65mmHg

  5. Heart rate [ Time Frame: 4 hours ]
    Number of heart beats per minute


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male or female patients
  • 18-45 years
  • ASA physical status I-II
  • scheduled for FESS operations

Exclusion Criteria:

  • uncontrolled hypertension
  • cerebrovascular disorders
  • coagulation disorders
  • cardiovascular diseases
  • renal impairment
  • liver impairment
  • history of allergic reaction to any of the study medications
Contacts and Locations

Locations
Layout table for location information
Egypt
Kasr Al Ainy
Cairo, Egypt, 11562
Sponsors and Collaborators
Cairo University
Tracking Information
First Submitted Date  ICMJE January 13, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date April 27, 2020
Actual Study Start Date  ICMJE January 19, 2019
Actual Primary Completion Date May 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019) 		Peripheral perfusion index [ Time Frame: 4 hours ]
Peripheral perfusion index will be used as a marker of peripheral perfusion.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • Change in serum lactate concentration [ Time Frame: Immediately before induction of anesthesia and after 60 minutes post recovery. ]
    Serum lactate concentration will be used as a marker of global tissue perfusion.Two samples will be obtained.
  • Total blood loss [ Time Frame: from beginning of surgery till the end of the procedure ]
    Total blood loss will be measured from the suction device and gauzes that will be used to dry the surgical field.
  • Surgical field score (SFS) [ Time Frame: from beginning of surgery till the end of the procedure. ]
    SFS ranges from 0 to 5 as follows: 0: No bleeding, 1: Slight bleeding-no suctioning of blood required, 2: Slight bleeding-occasional suctioning required. Surgical field not threatened. 3: Slight bleeding-frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed, 4: Moderate bleeding-frequent suctioning required. Bleeding threatens surgical field directly after suction is removed, 5: Severe bleeding-constant suctioning required. Bleeding appears faster that can be removed by suction. Surgical field severely threatened and surgery not possible. Adequate surgical field is defined as SFS <3
  • Mean arterial blood pressure [ Time Frame: 4 hours ]
    Target mean arterial pressure during deliberate hypotension will be 55-65mmHg
  • Heart rate [ Time Frame: 4 hours ]
    Number of heart beats per minute
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 Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension
Official Title  ICMJE Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension for Sinus Endoscopic Surgery.
Brief Summary Deliberate hypotension is used to provide bloodless field during endoscopic sinus surgery; however, hypotension might impair perfusion of vital organs. The aim of this work is to compare the impact of nitroglycerin and labetalol on peripheral perfusion when used for induction of deliberate hypotension
Detailed Description Hypotensive anesthesia is associated with the risk of reduced tissue perfusion. The usual target mean arterial pressure during deliberate hypotension is 50- 65 mmHg; however, the status of peripheral perfusion under this target is not well investigated. Nitroglycerin and Labetalol are commonly used drugs to achieve deliberate hypotension. Nitroglycerin is a direct vasodilator and its main action is through venodilation, while labetalol combines a selective α1 and non selective beta-adrenergic blocking activity. Both drugs were previously compared during deliberate hypotension with regard to surgical field quality and blood loss. No study to date compared the effects of both drugs on peripheral perfusion when used for induction of deliberate hypotension. The Peripheral Perfusion Index (PPI) is the ratio between pulsatile and non-pulsatile components of peripheral circulation. Measurement of PPI is based on analysis of the pulse oximetry signal. PPI showed increasing popularity as a non invasive monitor of peripheral perfusion. Serum lactate is another frequently used marker of global tissue perfusion.The aim of this study is to compare the influence of nitroglycerin and labetalol on tissue perfusion when used for induction of deliberate hypotension during FESS operations. Tissue perfusion will be evaluated using PPI and serum lactate as markers of peripheral and global tissue perfusion respectively.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Tissue Perfusion
  • Deliberate Hypotension
  • Sinus Endoscopic Surgery
Intervention  ICMJE
  • Drug: Nitroglycerin
    Nitroglycerin is a direct vasodilator and its main action is through venodilation. Nitroglycerin will be diluted by adding 3 mL (3 mg) to 47 mL normal saline in a 50 mL syringe and will be infused after endotracheal intubation with a starting dose of 0.5 mL/Kg/ hr to have a starting dose of 0.5 μg/Kg/min. The rate of nitroglycerin infusion will be 0.5-2 μg /kg/min .The infusion rate will be finely adjusted to maintain MAP around 55-65mmHg or till reaching adequate surgical field {defined as surgical field score (SFS) <3}.
  • Drug: Labetalol
    Labetalol is an α and β - adrenergic receptors competitive antagonist. Labetalol will be diluted by adding 10 mL (50 mg) to 40 mL normal saline in a 50 mL syringe and will be infused after endotracheal intubation with a starting dose of 0.5 mL/Kg/ hr. The rate of Labetalol infusion will be 0.5-2 mg/kg/h.The infusion rate will be finely adjusted to maintain MAP around 55-65mmHg or till reaching adequate surgical field {defined as surgical field score (SFS) <3}.
Study Arms  ICMJE
  • Experimental: group N
    Patients in this group will receive Nitroglycerin infusion for deliberate hypotension at a rate of 0.5-2 μg /kg/min .
    Intervention: Drug: Nitroglycerin
  • Active Comparator: group L
    Patients in this group will receive Labetalol infusion for deliberate hypotension at a rate of be 0.5-2 mg/kg/h .
    Intervention: Drug: Labetalol
Publications * Zayed M, Nassar H, Hasanin A, Saleh AH, Hassan P, Saad D, Mahmoud S, Abo Bakr G, Fouad E, Saleh N, Ismail M, El-Hadi H. Effects of nitroglycerin versus labetalol on peripheral perfusion during deliberate hypotension for sinus endoscopic surgery: a randomized, controlled, double-blinded trial. BMC Anesthesiol. 2020 Apr 17;20(1):85. doi: 10.1186/s12871-020-01006-w.

*   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 Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 25, 2019
Actual Primary Completion Date May 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult male or female patients
  • 18-45 years
  • ASA physical status I-II
  • scheduled for FESS operations

Exclusion Criteria:

  • uncontrolled hypertension
  • cerebrovascular disorders
  • coagulation disorders
  • cardiovascular diseases
  • renal impairment
  • liver impairment
  • history of allergic reaction to any of the study medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809065
Other Study ID Numbers  ICMJE N53-2016
Has Data Monitoring Committee Yes
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 Not Provided
Responsible Party Heba Nassar,MD, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date April 2020

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

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