Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension

Tissue Perfusion Clinical Trial

Official title:

Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension for Sinus Endoscopic Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03809065
• Other study ID #: N53-2016
• Status: Completed
• Phase: Phase 4
• Start date: January 19, 2019
• Est. completion date: May 25, 2019

Study information

• Verified date: April 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 25, 2019
• Est. primary completion date: May 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Deliberate Hypotension
• Hypotension
• Sinus Endoscopic Surgery
• Tissue Perfusion

Intervention

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}.
• Labetalol
Labetalol is an a and ß - 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}.

Locations

Country	Name	City	State
Egypt	Kasr Al Ainy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral perfusion index	Peripheral perfusion index will be used as a marker of peripheral perfusion.	4 hours
Secondary	Change in serum lactate concentration	Serum lactate concentration will be used as a marker of global tissue perfusion.Two samples will be obtained.	Immediately before induction of anesthesia and after 60 minutes post recovery.
Secondary	Total blood loss	Total blood loss will be measured from the suction device and gauzes that will be used to dry the surgical field.	from beginning of surgery till the end of the procedure
Secondary	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	from beginning of surgery till the end of the procedure.
Secondary	Mean arterial blood pressure	Target mean arterial pressure during deliberate hypotension will be 55-65mmHg	4 hours
Secondary	Heart rate	Number of heart beats per minute	4 hours