Effect of Hypotensive Anesthesia on the Perfusion Index

Early Phase 1

Completed

• Conditions: Controlled Hypotension for Nasal Surgeries
• Interventions: Combination Product: Massimo device; Drug: Nitroglycerin drug; Drug: Labetalol

• Registration Number: NCT03059316
• Lead Sponsor: Cairo University

Brief Summary

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.

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 Timeline

• Study Start: 2016-06-10
• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-23
• Primary Completion: 2017-04-10
• Study Completion: 2017-04-21
• Status Verified: 2019-01
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
labetalol group	Massimo device	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
nitroglycerin group	Massimo device	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
nitroglycerin group	Nitroglycerin drug	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
labetalol group	Labetalol	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

Primary Outcome Measures

Name	Time	Method
perfusion index	3hrs	perfusion index is an indication of peripheral perfusion
serum lactate level	3hrs	lactate level is an indication of central perfusion

Secondary Outcome Measures

Name	Time	Method
surgical feild score	3hrs	isan indication of adequacy of controlled hypotension