Peripheral Perfusion Index (PPI) as Monitor During Deliberate Hypotensive Anesthesia (PPI)

December 18, 2018 updated by: Abeer Ahmed, MD, Cairo University

The Use of Peripheral Perfusion Index as a Predictor for Patient's Response to Deliberate Hypotension During Functional Endoscopic Sinus Surgery A Prospective Observational Study

Hypotensive anesthesia is effective in reducing the intraoperative blood loss. The risk of hypoperfusion of vital organs continues to be a concern. An adequate monitoring of tissue perfusion and oxygenation is crucial issue. Peripheral Perfusion Index (PPI) as a noninvasive new monitoring, can reflect the peripheral perfusion dynamics.

This study is designed to explore the behaviour and trend of PPI during nitroglycerine induced deliberate hypotensive anesthesia in adult patients undergoing functional endoscopic sinus surgery (FESS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult male or females, aged between 18-50 years, ASA class I ans II

Description

Inclusion Criteria:

  • Patients, aged from 18-50 years, ASA physical status I and II, undergoing functional endoscopic sinus surgery (FESS) under deliberate hypotensive anesthesia

Exclusion Criteria:

  • Patients with systemic hypertension, cardiovascular disease, cerebrovascular insufficiency, coagulation defects, renal or hepatic insufficiency, and hypersensitivity to the study drugs will be excluded from the study. Patients receiving vasoactive drugs or beta blockers will be also excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between PPI and T1
Time Frame: start of nitroglyceirn infusion till target arterial pressure is reached up to 2 hours
correlation of baseline values of PPI and time required to achieve target mean arterial pressure.
start of nitroglyceirn infusion till target arterial pressure is reached up to 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

December 26, 2016

First Submitted That Met QC Criteria

December 29, 2016

First Posted (ESTIMATE)

January 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N 2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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