NCT00896714

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

8.2 years

First QC Date

May 8, 2009

Last Update Submit

August 13, 2019

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (1)

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

    during anesthesia

Secondary Outcomes (9)

  • Propofol dose required for anesthesia induction

    intraoperative period

  • Remifentanil dose required for anesthesia induction

    intraoperative period

  • Remifentanil dose requirements for maintenance of anesthesia

    intraoperative period

  • Wake up time

    intraoperative period

  • Explicit memorisation

    post-operative period

  • +4 more secondary outcomes

Study Arms (1)

Closed loop anesthesia

EXPERIMENTAL
Device: Closed loop anesthesia

Interventions

Closed loop anesthesiaDEVICE

Propofol and Remifentanil are administered automatically using a closed-loop system

Closed loop anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Besançon

Besançon, 25000, France

Location

Centre Hospitalier de Dreux

Dreux, 28102, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Hôpital Foch

Suresnes, 92151, France

Location

Study Officials

  • Marc Fischler, MD

    Hôpital Foch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2009

First Posted

May 12, 2009

Study Start

May 4, 2009

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

FR(4)