Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension

NCT03809065 | Completed Phase 4 DMC

• 1 other identifier: N53-2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Tissue Perfusion; Deliberate Hypotension; Sinus Endoscopic Surgery

Keywords

Deliberate hypotension; Nitroglycerin; Labetalol; Peripheral perfusion

Outcome Measures

Primary Outcomes (1)

• Peripheral perfusion index

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

  4 hours

Secondary Outcomes (5)

• Change in serum lactate concentration

  Immediately before induction of anesthesia and after 60 minutes post recovery.

• Total blood loss

  from beginning of surgery till the end of the procedure

• Surgical field score (SFS)

  from beginning of surgery till the end of the procedure.

• Mean arterial blood pressure

  4 hours

• Heart rate

  4 hours

Study Arms (2)

group N

EXPERIMENTAL

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

Drug: Nitroglycerin

group L

ACTIVE COMPARATOR

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

Drug: Labetalol

Interventions

Nitroglycerin DRUG

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}.

group N

Labetalol DRUG

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}.

group L

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Al Ainy

Cairo, 11562, Egypt

Location

Related Publications (1)

• 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.

  PMID: 32303182 DERIVED

MeSH Terms

Interventions

Nitroglycerin; Labetalol

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Ethanolamines; Amino Alcohols; Alcohols; Salicylamides; Amides; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Anesthesia

Study Record Dates

• First Submitted: January 13, 2019
• First Posted: January 18, 2019
• Study Start: January 19, 2019
• Primary Completion: May 25, 2019
• Study Completion: May 25, 2019
• Last Updated: April 27, 2020

Record last verified: 2020-04

Locations

EG (1)