Factors Influencing Anesthetic Drug Requirement (PosoAnes)

Tracking Information
First Submitted Date ICMJE	May 8, 2009
First Posted Date ICMJE	May 12, 2009
Last Update Posted Date	March 28, 2017
Study Start Date ICMJE	May 2009
Actual Primary Completion Date	May 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 19, 2016)	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; (submitted: May 8, 2009)	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; (submitted: March 24, 2017)	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; (submitted: May 8, 2009)	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 Applicable
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; (submitted: April 19, 2016)	5000
Original Estimated Enrollment ICMJE; (submitted: May 8, 2009)	4500
Estimated Study Completion Date	June 2017
Actual 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	No
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	No
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