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Factors Influencing Anesthetic Drug Requirement (PosoAnes)

This study is currently recruiting participants.
Verified July 2012 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00896714
First received: May 8, 2009
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Anesthesia, General
 Drug: Propofol ; Remifentanil
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Environmental and Demographic Factors on Pre-operative Doses of Anesthetic Agents (Prospective Multicenter Study)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 4500
Study Start Date: May 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Propofol ; Remifentanil
    Propofol and Remifentanil administered automatically using a closed-loop system
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896714

Contacts
Contact: Marc Fischler, MD 46252442 ext 00331 m.fischler@hopital-foch.org

Locations
France
Clinique de la Baie des Citrons Recruiting
Nouméa, Nouvelle Calédonie, France, 98800
Contact: Alain , Charmeau     00261866 ext 0033     charmeau@offratel.nc    
Principal Investigator: Alain Charmeau, MD            
CHU Besançon Recruiting
Besançon, France, 25000
Contact: Nathalie Boichut, MD     381668166 ext 00331     nboichut@chu-besancon.fr    
Principal Investigator: Nathalie Boichut, MD            
Centre Hospitalier de Dreux Recruiting
Dreux, France, 28102
Contact: T. Herail, MD         therail@free.fr    
Principal Investigator: T. Herail, MD            
Hôpital Tenon Recruiting
Paris, France, 75020
Contact: Francis Bonnet, MD     56016571 ext 00331     francis.bonnet@tnn.aphp.fr    
Principal Investigator: Francis Bonnet, MD            
Hôpital Foch Recruiting
Suresnes, France, 92151
Contact: Marc Fischler, MD     46252442 ext 00331     m.fischler@hopital-foch.org    
Principal Investigator: Thierry Chazot, MD            
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hôpital Foch
  More Information

No publications provided

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT00896714     History of Changes
Other Study ID Numbers: 2008/44
Study First Received: May 8, 2009
Last Updated: July 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Anesthetics
Propofol
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013