Effect of Hypotensive Anesthesia on the Perfusion Index

Department of Anestheia and Intensive Care Unit,Cairo University

Controlled hypotension has been used as a mean of reducing intraoperative blood loss and better visualization of the surgical field in nasal surgeries. Perfusion index has been considered a useful tool for monitoring changes in peripheral perfusion using Masimo set and serum lactate for central perfusion. Many medications were used to induce hypotension. In this study we will compare the effects of tridil and labetalol on the perfusion.

Study Overview

• Status: Completed
• Conditions: Controlled Hypotension for Nasal Surgeries
• Intervention / Treatment: Combination product: Massimo device; Drug: Nitroglycerin drug; Drug: Labetalol

Detailed Description

The purpose of this study to detect the degree of hypotension that helps the surgeon and dosen't impair patient's perfusion and to compare the hypotensive effects of both tridil and labetalol infusions on the perfusion.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I-II males and females aged 18-45 years who were scheduled for Functional Endoscopic sinus surgery (FESS)

Exclusion Criteria:

• uncontrolled hypertension, cerebrovascular disorders, bleeding and coagulation disorders, coronary artery diseases, renal or hepatic diseases or known hypersensitivity to the drugs used and pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: nitroglycerin group; this group will receive nitroglycerin infusion for controlled hypotension.0.5-5ug/kg/min to keep MAP 55-65mmhg then Massimo device will be attached to the patients when MAP reached the desired level	Combination product: Massimo device; Massimo is a newly introduced device which can measure the peripheral organ perfusion and expressed it as perfusion index(PI).; Drug: Nitroglycerin drug; Nitroglycerin is a drug used as an hypotensive agent through its vasodilation effect on veins; Other Names: tridil
Active Comparator: labetalol group; this group will receive labetalol infusion fo controlled hypotension 0.4-3mg/kg/hr to keep MAP 55-65mmhg.then Massimo device will be attached to the patients when MAP reached the desired level	Combination product: Massimo device; Massimo is a newly introduced device which can measure the peripheral organ perfusion and expressed it as perfusion index(PI).; Drug: Labetalol; Labetalol is an antagonist of adrenergic receptors (a1, b1, b2) which is used as an hypotensive inducer. This drug targets the beta receptors 5 to 10 times more specific than alpha receptors so that minor tachycardia happens; Other Names: trendate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perfusion index	perfusion index is an indication of peripheral perfusion	3hrs
serum lactate level	lactate level is an indication of central perfusion	3hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgical feild score	isan indication of adequacy of controlled hypotension	3hrs

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2016
• Primary Completion (Actual): April 10, 2017
• Study Completion (Actual): April 21, 2017

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: controlled hypotension, perfusion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympathomimetics; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Nitroglycerin; Labetalol
• Other Study ID Numbers: N532016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No