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Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia

NCT ID: NCT01020643

Last Updated: 2013-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Conscious Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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controlled sedation using propofol

Group Type EXPERIMENTAL

controlled administration of propofol

Intervention Type DRUG

comparison of propofol sedation

Interventions

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controlled administration of propofol

comparison of propofol sedation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients undergoing hip or knee replacement under spinal anesthesia

Exclusion Criteria

* contraindication to spinal anesthesia
* allergies to any study drug
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas Hemmerling

OTHER

Sponsor Role lead

Responsible Party

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Thomas Hemmerling

MSc, MD, DEAA,

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Thomas Hemmerling, MD

Role: PRINCIPAL_INVESTIGATOR

MUHC - MGH

Locations

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MUHC - Montreal General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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09-168-GEN

Identifier Type: -

Identifier Source: org_study_id