Factors Influencing Anesthetic Drug Requirement

NCT ID: NCT00896714

Last Updated: 2019-08-14

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

NA

Total Enrollment

3278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-04

Study Completion Date

2017-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Anesthesia, General

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Closed loop anesthesia

Group Type EXPERIMENTAL

Closed loop anesthesia

Intervention Type DEVICE

Propofol and Remifentanil are administered automatically using a closed-loop system

Interventions

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Closed loop anesthesia

Propofol and Remifentanil are administered automatically using a closed-loop system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Fischler, MD

Role: STUDY_CHAIR

Hôpital Foch

Locations

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CHU Besançon

Besançon, , France

Site Status

Centre Hospitalier de Dreux

Dreux, , France

Site Status

Hôpital Tenon

Paris, , France

Site Status

Hôpital Foch

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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2008/44

Identifier Type: -

Identifier Source: org_study_id

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