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NCT01019746 Clinical Trial

Controlled Propofol Administration

HYPNOSIS Clinical Trial

Official title:
Comparison of Closed-oop of Propofol Versus Manual Control Using Bispectral Index (BIS)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01019746
Other study ID # GEN-07-002
Secondary ID GEN#07-002
Status Completed
Phase Phase 4
First received November 23, 2009
Last updated November 23, 2009
Start date August 2007

Study information
Verified date November 2009
Source McGill University Health Center
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• propofol
propofol administration

Locations
Country Name City State
Canada MUHC - Montreal General Hospital Montreal Quebec

Sponsors (1)
Lead Sponsor Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of control administration of propofol with manual administration. 1 year No
Secondary Emergence from anesthesia 1 year No
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