Factors Influencing Anesthetic Drug Requirement | NCT00896714

Studies
Factors Influencing Anesthetic Drug Requirement

NCT00896714

Sponsor

Hopital Foch

Status

Completed

Last Update Posted

Aug 14, 2019Actual

Enrollment

3,278Actual

Phase

Not Applicable

Conditions

Anesthesia, General

Interventions

Closed loop anesthesia

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 4, 2009Actual

Primary Completion Date

Jul 31, 2017Actual

Completion Date

Jul 31, 2017Actual

First Submitted Date

May 8, 2009

First Submission Date that Met QC Criteria

May 8, 2009

First Posted Date

May 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2019

Last Update Posted Date

Aug 14, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3,278Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Closed loop anesthesia	Experimental		Device: Closed loop anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Closed loop anesthesia	Device	Propofol and Remifentanil are administered automatically using a closed-loop system	Closed loop anesthesia

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Propofol dose required for anesthesia induction		intraoperative period
Remifentanil dose required for anesthesia induction		intraoperative period
Remifentanil dose requirements for maintenance of anesthesia

Other Outcomes

Not provided

Eligibility Module

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
Surgery on the skull and/or operating position preventing the use of a bispectral index sensor in suitable conditions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Fischler, MD	Hôpital Foch	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Besançon		Besançon		25000	France
Centre Hospitalier de Dreux