Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia

Phase 4CompletedNCT01020643

Thomas Hemmerling203 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

203

Conditions

Conscious Sedation

Interventions

controlled administration of propofolDRUG

comparison of propofol sedation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients undergoing hip or knee replacement under spinal anesthesia Exclusion Criteria: * contraindication to spinal anesthesia * allergies to any study drug

Locations (1)

MUHC - Montreal General Hospital

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Controller performance

Time frame: 1 year

Secondary Outcomes

fluid management

fluid management manual versus guided

Time frame: end of surgery

Data from ClinicalTrials.gov

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