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Factors Influencing Anesthetic Drug Requirement (PosoAnes)

This study is currently recruiting participants.
Verified March 2017 by Hopital Foch
Sponsor:
ClinicalTrials.gov Identifier:
NCT00896714
First Posted: May 12, 2009
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hopital Foch
May 8, 2009
May 12, 2009
March 28, 2017
May 2009
May 2016   (Final data collection date for primary outcome measure)
The dose of propofol required to maintain BIS (bispectral index) between 40 and 60 during maintenance of anesthesia [ Time Frame: during anesthesia ]
The dose of propofol required to maintain BIS between 40 and 60 during maintenance of anesthesia [ Time Frame: during anesthesia ]
Complete list of historical versions of study NCT00896714 on ClinicalTrials.gov Archive Site
  • 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)
  • 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 ]
Not Provided
Not Provided
 
Factors Influencing Anesthetic Drug Requirement
Impact of Environmental and Demographic Factors on Pre-operative Doses of Anesthetic Agents (Prospective Multicenter Study)
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).
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Anesthesia, General
Device: Closed loop anesthesia
Propofol and Remifentanil are administered automatically using a closed-loop system
Experimental: Closed loop anesthesia
Intervention: Device: Closed loop anesthesia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
June 2017
May 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Marc Fischler, MD 46252442 ext 00331 m.fischler@hopital-foch.org
France
 
 
NCT00896714
2008/44
No
Not Provided
Not Provided
Hopital Foch
Hopital Foch
Not Provided
Study Chair: Marc Fischler, MD Hôpital Foch
Hopital Foch
March 2017

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