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NCT Number: NCT03059316

Effect of Hypotensive Anesthesia on the Perfusion Index

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.

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Key information

Conditions

Controlled Hypotension for Nasal Surgeries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Massimo device

Combination Product

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

Nitroglycerin drug

Drug

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

Other names: tridil

labetalol

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

Other names: trendate

Primary outcomes

  1. perfusion index

    Time frame: 3hrs

    perfusion index is an indication of peripheral perfusion

  2. serum lactate level

    Time frame: 3hrs

    lactate level is an indication of central perfusion

Secondary outcomes

  1. surgical feild score

    Time frame: 3hrs

    isan indication of adequacy of controlled hypotension

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Department of Anestheia and Intensive Care Unit,Cairo University

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 23, 2017
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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