Impact of Environmental and Demographic Factors on Pre-operative Doses of Anesthetic Agents (Prospective Multicenter Study)

Hopital Foch4 sites in 1 country3,278 target enrollmentMay 4, 2009

ConditionsAnesthesia, General

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anesthesia, General
Sponsor: Hopital Foch
Enrollment: 3278
Locations: 4
Primary Endpoint: The dose of propofol required to maintain BIS (bispectral index) between 40 and 60 during maintenance of anesthesia
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

May 4, 2009

End Date

July 31, 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hopital Foch

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

The dose of propofol required to maintain BIS (bispectral index) between 40 and 60 during maintenance of anesthesia

Time Frame: during anesthesia

Secondary Outcomes

Wake up time(intraoperative period)
Remifentanil dose requirements for maintenance of anesthesia(intraoperative period)
Remifentanil dose required for anesthesia induction(intraoperative period)
Propofol and remifentanil requirements according to the surgical technique(post-operative period)
Analysis of subgroup of patients according to their clinical status(post-operative period)
Analysis of subgroup of patients according to the surgical approach(post-operative period)
Analysis of subgroup of patients according to their pathology(post-operative period)
Propofol dose required for anesthesia induction(intraoperative period)
Explicit memorisation(post-operative period)