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Clinical Trials/NCT03059316
NCT03059316
Completed
Early Phase 1

Department of Anestheia and Intensive Care Unit,Cairo University

Cairo University0 sites40 target enrollmentJune 10, 2016

Overview

Phase
Early Phase 1
Intervention
Massimo device
Conditions
Controlled Hypotension for Nasal Surgeries
Sponsor
Cairo University
Enrollment
40
Primary Endpoint
perfusion index
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 10, 2016
End Date
April 21, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amany Hassan Saleh

department of anesthesia and intensive care unit,Cairo university

Cairo University

Eligibility Criteria

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.

Arms & Interventions

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

Intervention: Massimo device

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

Intervention: Nitroglycerin drug

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

Intervention: Massimo device

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

Intervention: Labetalol

Outcomes

Primary Outcomes

perfusion index

Time Frame: 3hrs

perfusion index is an indication of peripheral perfusion

serum lactate level

Time Frame: 3hrs

lactate level is an indication of central perfusion

Secondary Outcomes

  • surgical feild score(3hrs)

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