NCT01020643

Brief Summary

The purpose of this study is to compare the administration of a standard anesthetic drug (propofol) using an automatic, expert-based system versus a manually controlled system by the anesthesiologist. In addition, the performance of the decision support system will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2009

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

November 1, 2009

Completed
22 days 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
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

October 25, 2013

Status Verified

October 1, 2013

Enrollment Period

1.7 years

First QC Date

November 23, 2009

Last Update Submit

October 24, 2013

Conditions

Conscious Sedation

Outcome Measures

Primary Outcomes (1)

  • Controller performance

    1 year

Secondary Outcomes (1)

  • fluid management

    end of surgery

Study Arms (1)

controlled sedation using propofol

EXPERIMENTAL
Drug: controlled administration of propofol

Interventions

controlled administration of propofolDRUG

comparison of propofol sedation

controlled sedation using propofol

Eligibility Criteria

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

You may qualify if:

  • patients undergoing hip or knee replacement under spinal anesthesia

You may not qualify if:

  • contraindication to spinal anesthesia
  • allergies to any study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUHC - Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Study Officials

  • Thomas Hemmerling, MD

    MUHC - MGH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSc, MD, DEAA,

Study Record Dates

First Submitted

November 23, 2009

First Posted

November 25, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

October 25, 2013

Record last verified: 2013-10

Locations

CA(1)