Clinical trial NCT03809065: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tissue Perfusion
Deliberate Hypotension
Sinus Endoscopic Surgery
Keywords: Deliberate hypotension
Nitroglycerin
Labetalol
Peripheral perfusion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Peripheral perfusion index
timeFrame: 4 hours
Secondary outcomes:
measure: Change in serum lactate concentration
timeFrame: Immediately before induction of anesthesia and after 60 minutes post recovery.
measure: Total blood loss
timeFrame: from beginning of surgery till the end of the procedure
measure: Surgical field score (SFS)
timeFrame: from beginning of surgery till the end of the procedure.
measure: Mean arterial blood pressure
timeFrame: 4 hours
measure: Heart rate
timeFrame: 4 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Ainy
Study officials:
References:
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.