Pupillometry Guided Remifentanil Administration and Total Opioid Consumption During Propofol - Remifentanil TCI

October 16, 2015 updated by: Pr Isabelle CONSTANT

Pupillometry Guided Versus Standard Practice Remifentanil Administration and Total Opioid Consumption

The aim of this prospective randomized study was to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in major gynecological surgery. All patients were anesthetized with TCI of propofol and remifentanil. In the intervention group, peroperative remifentanil target was guided by pupillometry. In the other group, remifentanil was administered according to standard practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Departement d'anesthesie Hopital Armand Trousseau

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ASA I-II
  • Elective gynecological surgery
  • No ophtalmologic or neurologic disease
  • No chronic analgesic medication
  • Expected length of surgery 60 minutes minimum

Exclusion Criteria:

  • ophtalmologic or neurologic disease
  • chronic analgesic medication

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PUPILLO
Videopupillometer Algiscan peroperative remifentanil target concentration adapted every five minutes to pupillary diameter in patients under propofol and remifentanil TCI
Device: Videopupillometer Algiscan
pupillary diameter measurement every five minutes per-operatively
Drug: Propofol
TCI
Drug: Remifentanil
TCI
Sham Comparator: STANDARD
peroperative remifentanil target concentration as standard practice in patients under propofol and remifentanil TCI
Drug: Propofol
TCI
Drug: Remifentanil
TCI
Other: Standard practice
remifentanil administration left to the discretion of the anesthesiologist in charge according to standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
peroperative remifentanil consumption in µg/kg/min
Time Frame: duration of surgery
duration of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative morphine requirements in mg/kg
Time Frame: 24 hours
includes initial morphine titration and subsequent PCA use
24 hours
peroperative propofol consumption in mg/kg/h
Time Frame: duration of surgery
duration of surgery

Collaborators and Investigators

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

Sponsor

Pr Isabelle CONSTANT

Investigators

  • Study Director: Isabelle Constant, MD-PHD, Hôpital Armand Trousseau

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

October 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

October 13, 2015

First Posted (Estimate)

October 15, 2015

Study Record Updates

Last Update Posted (Estimate)

October 19, 2015

Last Update Submitted That Met QC Criteria

October 16, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anesthesie Trousseau 001

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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