NCT01019746

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

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

August 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

9 months

First QC Date

November 23, 2009

Last Update Submit

November 23, 2009

Conditions

HYPNOSIS

Keywords

Hypnosis with propofol

Outcome Measures

Primary Outcomes (1)

  • Comparison of control administration of propofol with manual administration.

    1 year

Secondary Outcomes (1)

  • Emergence from anesthesia

    1 year

Study Arms (1)

control propofol administration

EXPERIMENTAL
Drug: propofol

Interventions

propofolDRUG

propofol administration

control propofol administration

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • inability to provide informed consent
  • allergies to study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUHC - Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 20533013DERIVED

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 23, 2009

First Posted

November 25, 2009

Study Start

August 1, 2007

Primary Completion

May 1, 2008

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

CA(1)