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Factors Influencing Anesthetic Drug Requirement (PosoAnes)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00896714
First received: May 8, 2009
Last updated: September 22, 2016
Last verified: September 2016
History of Changes

May 8, 2009
September 22, 2016
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00896714 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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
Phase 3
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Active, not recruiting
5000
December 2016
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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00896714
2008/44
No
Not Provided
Not Provided
Hopital Foch
Hopital Foch
Not Provided
Study Chair: Marc Fischler, MD Hôpital Foch
Hopital Foch
September 2016

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