Effect of Hypotensive Anesthesia on the Perfusion Index

NCT ID: NCT03059316

Last Updated: 2019-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-10

Study Completion Date

2017-04-21

Brief Summary

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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

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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.

Conditions

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Controlled Hypotension for Nasal Surgeries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Massimo device

Intervention Type COMBINATION_PRODUCT

Massimo is a newly introduced device which can measure the peripheral organ perfusion and expressed it as perfusion index(PI).

Nitroglycerin drug

Intervention Type DRUG

Nitroglycerin is a drug used as an hypotensive agent through its vasodilation effect on veins

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

Group Type ACTIVE_COMPARATOR

Massimo device

Intervention Type COMBINATION_PRODUCT

Massimo is a newly introduced device which can measure the peripheral organ perfusion and expressed it as perfusion index(PI).

Labetalol

Intervention Type DRUG

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

Interventions

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Massimo device

Massimo is a newly introduced device which can measure the peripheral organ perfusion and expressed it as perfusion index(PI).

Intervention Type COMBINATION_PRODUCT

Nitroglycerin drug

Nitroglycerin is a drug used as an hypotensive agent through its vasodilation effect on veins

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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tridil trendate

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amany Hassan Saleh

department of anesthesia and intensive care unit,Cairo university

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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N532016

Identifier Type: -

Identifier Source: org_study_id

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