Factors Influencing Anesthetic Drug Requirement

Not Applicable

Completed

• Conditions: Anesthesia, General
• Interventions: Device: Closed loop anesthesia

• Registration Number: NCT00896714
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-04
• Study First Submitted: 2009-05-08
• Study First Submitted QC: 2009-05-08
• Study First Posted: 2009-05-12
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3278

Inclusion Criteria

• Patients undergoing scheduled surgery under general anesthesia, agreeing to participate in the study

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Closed loop anesthesia	Closed loop anesthesia	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 their clinical status (eg: age)
Analysis of subgroup of patients according to the surgical approach	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	post-operative period	analysis of subgroup of patients according to their pathology (eg: burns)
Propofol dose required for anesthesia induction	intraoperative period
Explicit memorisation	post-operative period

Trial Locations

Locations (4)

Hôpital Foch; 🇫🇷 Suresnes, France

Hôpital Tenon; 🇫🇷 Paris, France

Centre Hospitalier de Dreux; 🇫🇷 Dreux, France

CHU Besançon; 🇫🇷 Besançon, France