Factors Influencing Anesthetic Drug Requirement (PosoAnes)

This study is currently recruiting participants. (see Contacts and Locations)

Verified September 2014 by Hopital Foch

Sponsor:

Information provided by (Responsible Party):

Hopital Foch

ClinicalTrials.gov Identifier:

NCT00896714

First received: May 8, 2009

Last updated: September 23, 2014

Last verified: September 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

May 8, 2009

Last Updated Date

September 23, 2014

Start Date ^ICMJE

May 2009

Estimated Primary Completion Date

July 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The dose of propofol required to maintain BIS between 40 and 60 during maintenance of anesthesia [ Time Frame: during anesthesia ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00896714 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Propofol dose required for anesthesia induction [ Time Frame: intraoperative period ] [ Designated as safety issue: No ]
Remifentanil dose required for anesthesia induction [ Time Frame: intraoperative period ] [ Designated as safety issue: No ]
Remifentanil dose requirements for maintenance of anesthesia [ Time Frame: intraoperative period ] [ Designated as safety issue: No ]
Wake up time [ Time Frame: intraoperative period ] [ Designated as safety issue: No ]
Explicit memorisation [ Time Frame: post-operative period ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Factors Influencing Anesthetic Drug Requirement

Official Title ^ICMJE

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

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Anesthesia, General

Intervention ^ICMJE

Drug: Propofol ; Remifentanil

Propofol and Remifentanil administered automatically using a closed-loop system

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

4500

Estimated Completion Date

July 2015

Estimated Primary Completion Date

July 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Marc Fischler, MD

46252442 ext 00331

m.fischler@hopital-foch.org

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00896714

Other Study ID Numbers ^ICMJE

2008/44

Has Data Monitoring Committee

Responsible Party

Hopital Foch

Study Sponsor ^ICMJE

Hopital Foch

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Marc Fischler, MD

Hôpital Foch

Information Provided By

Hopital Foch

Verification Date

September 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top