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Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension

Primary Purpose

Tissue Perfusion, Deliberate Hypotension, Sinus Endoscopic Surgery

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Nitroglycerin
Labetalol
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tissue Perfusion focused on measuring Deliberate hypotension, Nitroglycerin, Labetalol, Peripheral perfusion

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kasr Al Ainy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group N

group L

Arm Description

Patients in this group will receive Nitroglycerin infusion for deliberate hypotension at a rate of 0.5-2 μg /kg/min .

Patients in this group will receive Labetalol infusion for deliberate hypotension at a rate of be 0.5-2 mg/kg/h .

Outcomes

Primary Outcome Measures

Peripheral perfusion index
Peripheral perfusion index will be used as a marker of peripheral perfusion.

Secondary Outcome Measures

Change in serum lactate concentration
Serum lactate concentration will be used as a marker of global tissue perfusion.Two samples will be obtained.
Total blood loss
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)
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
Target mean arterial pressure during deliberate hypotension will be 55-65mmHg
Heart rate
Number of heart beats per minute

Full Information

First Posted
January 13, 2019
Last Updated
April 23, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03809065
Brief Title
Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension
Official Title
Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension for Sinus Endoscopic Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 19, 2019 (Actual)
Primary Completion Date
May 25, 2019 (Actual)
Study Completion Date
May 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tissue Perfusion, Deliberate Hypotension, Sinus Endoscopic Surgery
Keywords
Deliberate hypotension, Nitroglycerin, Labetalol, Peripheral perfusion

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group N
Arm Type
Experimental
Arm Description
Patients in this group will receive Nitroglycerin infusion for deliberate hypotension at a rate of 0.5-2 μg /kg/min .
Arm Title
group L
Arm Type
Active Comparator
Arm Description
Patients in this group will receive Labetalol infusion for deliberate hypotension at a rate of be 0.5-2 mg/kg/h .
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin
Intervention Description
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}.
Intervention Type
Drug
Intervention Name(s)
Labetalol
Intervention Description
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}.
Primary Outcome Measure Information:
Title
Peripheral perfusion index
Description
Peripheral perfusion index will be used as a marker of peripheral perfusion.
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Change in serum lactate concentration
Description
Serum lactate concentration will be used as a marker of global tissue perfusion.Two samples will be obtained.
Time Frame
Immediately before induction of anesthesia and after 60 minutes post recovery.
Title
Total blood loss
Description
Total blood loss will be measured from the suction device and gauzes that will be used to dry the surgical field.
Time Frame
from beginning of surgery till the end of the procedure
Title
Surgical field score (SFS)
Description
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
Time Frame
from beginning of surgery till the end of the procedure.
Title
Mean arterial blood pressure
Description
Target mean arterial pressure during deliberate hypotension will be 55-65mmHg
Time Frame
4 hours
Title
Heart rate
Description
Number of heart beats per minute
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kasr Al Ainy
City
Cairo
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
32303182
Citation
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.
Results Reference
derived

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Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension

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