Factors Influencing Anesthetic Drug Requirement (PosoAnes)

August 13, 2019 updated by: Hopital Foch

Impact of Environmental and Demographic Factors on Pre-operative Doses of Anesthetic Agents (Prospective Multicenter Study)

The main objective of the study is to analyze the influence of several environmental (i.e., timing: seasonal, circadian) and demographic conditions (i.e., age, gender, menstrual cycle) on anesthetic drug requirements (hypnotic and opiate).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3278

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
      • Besançon, France, 25000
        • CHU Besançon
      • Dreux, France, 28102
        • Centre Hospitalier de Dreux
      • Paris, France, 75020
        • Hopital Tenon
      • Suresnes, France, 92151
        • Hopital Foch

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing scheduled surgery under general anesthesia, agreeing to participate in the study

Exclusion Criteria:

  • Age under 18 years
  • Pregnancy, breastfeeding woman
  • Allergy to propofol, soybeans or peanuts
  • Allergy to sufentanil, remifentanil, morphine,
  • Allergy to a muscle relaxant or to any of its excipients
  • Known hypersensitivity to sufentanil, remifentanil, or to other derivates of fentanyl
  • History of central neurological disorder or brain injury
  • Patient with dementia
  • Patient with pacemaker
  • Patient receiving psychotropic drugs or morphine agonist-antagonists
  • Surgery on the skull and/or operating position preventing the use of a bispectral index sensor in suitable conditions

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Closed loop anesthesia
Device: Closed loop anesthesia
Propofol and Remifentanil are administered automatically using a closed-loop system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The dose of propofol required to maintain BIS (bispectral index) between 40 and 60 during maintenance of anesthesia
Time Frame: during anesthesia
during anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Propofol dose required for anesthesia induction
Time Frame: intraoperative period
intraoperative period
Remifentanil dose required for anesthesia induction
Time Frame: intraoperative period
intraoperative period
Remifentanil dose requirements for maintenance of anesthesia
Time Frame: intraoperative period
intraoperative period
Wake up time
Time Frame: intraoperative period
intraoperative period
Explicit memorisation
Time Frame: post-operative period
post-operative period
Propofol and remifentanil requirements according to the surgical technique
Time Frame: post-operative period
post-operative period
Analysis of subgroup of patients according to their clinical status
Time Frame: post-operative period
analysis of subgroup of patients according to their clinical status (eg: age)
post-operative period
Analysis of subgroup of patients according to the surgical approach
Time Frame: post-operative period
analysis of subgroup of patients according to the surgical approach ("open" surgery versus "minimal invasive" surgery)
post-operative period
Analysis of subgroup of patients according to their pathology
Time Frame: post-operative period
analysis of subgroup of patients according to their pathology (eg: burns)
post-operative period

Collaborators and Investigators

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

Sponsor

Hopital Foch

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 (Actual)

May 4, 2009

Primary Completion (Actual)

July 31, 2017

Study Completion (Actual)

July 31, 2017

Study Registration Dates

First Submitted

May 8, 2009

First Submitted That Met QC Criteria

May 8, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/44

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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