Factors Influencing Anesthetic Drug Requirement (PosoAnes)

This study is currently recruiting participants.

See

Contacts and Locations

Verified March 2017 by Hopital Foch

Sponsor:

Information provided by (Responsible Party):

Hopital Foch

ClinicalTrials.gov Identifier:

NCT00896714

First received: May 8, 2009

Last updated: March 24, 2017

Last verified: March 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

May 8, 2009

Last Updated Date

March 24, 2017

Start Date ^ICMJE

May 2009

Primary Completion Date

May 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

The dose of propofol required to maintain BIS between 40 and 60 during maintenance of anesthesia [ Time Frame: during anesthesia ]

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 ]
Remifentanil dose required for anesthesia induction [ Time Frame: intraoperative period ]
Remifentanil dose requirements for maintenance of anesthesia [ Time Frame: intraoperative period ]
Wake up time [ Time Frame: intraoperative period ]
Explicit memorisation [ Time Frame: post-operative period ]
Propofol and remifentanil requirements according to the surgical technique [ Time Frame: 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)
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)
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)

Original Secondary Outcome Measures ^ICMJE

Propofol dose required for anesthesia induction [ Time Frame: intraoperative period ]
Remifentanil dose required for anesthesia induction [ Time Frame: intraoperative period ]
Remifentanil dose requirements for maintenance of anesthesia [ Time Frame: intraoperative period ]
Wake up time [ Time Frame: intraoperative period ]
Explicit memorisation [ Time Frame: post-operative period ]

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

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Anesthesia, General

Intervention ^ICMJE

Device: Closed loop anesthesia

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

Study Arms

Experimental: Closed loop anesthesia

Intervention: Device: Closed loop anesthesia

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

5000

Estimated Completion Date

June 2017

Primary Completion Date

May 2016 (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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

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

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Hopital Foch

Study Sponsor ^ICMJE

Hopital Foch

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Marc Fischler, MD

Hôpital Foch

PRS Account

Hopital Foch

Verification Date

March 2017

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

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