Controlled Propofol Administration | NCT01019746

Studies
Controlled Propofol Administration

NCT01019746

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Status

Completed

Last Update Posted

Nov 25, 2009Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

HYPNOSIS

Interventions

propofol

Countries

Canada

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

ID	Type	Description	Link
GEN#07-002

Status Module

Record Verification Date

Nov 2009

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

Aug 2007

Primary Completion Date

May 2008Actual

Completion Date

Not provided

First Submitted Date

Nov 23, 2009

First Submission Date that Met QC Criteria

Nov 23, 2009

First Posted Date

Nov 25, 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

Nov 23, 2009

Last Update Posted Date

Nov 25, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER

Collaborators

Not provided

Description Module

Brief Summary

The purpose of this study is to compare the administration of the standard anesthetic agent (propofol) using this automatic system with the manual administration of propofol by the anesthesiologist.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control propofol administration	Experimental		Drug: propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
propofol	Drug	propofol administration	control propofol administration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of control administration of propofol with manual administration.		1 year

Secondary Outcomes

Measure	Description	Time Frame
Emergence from anesthesia		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients aged 18 to 90 years
surgery lasting more than 30 min

Exclusion Criteria:

inability to provide informed consent
allergies to study drug

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MUHC - Montreal General Hospital		Montreal	Quebec	H3G 1A4	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20533013	Derived	Hemmerling TM, Charabati S, Zaouter C, Minardi C, Mathieu PA. A randomized controlled trial demonstrates that a novel closed-loop propofol system performs better hypnosis control than manual administration. Can J Anaesth. 2010 Aug;57(8):725-35. doi: 10.1007/s12630-010-9335-z. Epub 2010 Jun 9.

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic