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Factors Influencing Anesthetic Drug Requirement (PosoAnes)

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ClinicalTrials.gov Identifier: NCT00896714
Recruitment Status : Recruiting
First Posted : May 12, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

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).

Condition or disease Intervention/treatment Phase
Anesthesia, General Device: Closed loop anesthesia Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Environmental and Demographic Factors on Pre-operative Doses of Anesthetic Agents (Prospective Multicenter Study)
Study Start Date : May 2009
Actual Primary Completion Date : May 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

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




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

Secondary Outcome Measures :
  1. Propofol dose required for anesthesia induction [ Time Frame: intraoperative period ]
  2. Remifentanil dose required for anesthesia induction [ Time Frame: intraoperative period ]
  3. Remifentanil dose requirements for maintenance of anesthesia [ Time Frame: intraoperative period ]
  4. Wake up time [ Time Frame: intraoperative period ]
  5. Explicit memorisation [ Time Frame: post-operative period ]
  6. Propofol and remifentanil requirements according to the surgical technique [ Time Frame: post-operative period ]
  7. 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)

  8. 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)

  9. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT00896714     History of Changes
Other Study ID Numbers: 2008/44
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs