Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia

Comparison of Closed-loop Control System of Propofol Versus Manual Control Using Bispectral Index for Controlled Sedation - a Pilot Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01020643

Enrollment

203

Registered

2009-11-25

Start date

2009-11-30

Completion date

2011-08-31

Last updated

2013-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conscious Sedation

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.

Interventions

DRUGcontrolled administration of propofol

comparison of propofol sedation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* patients undergoing hip or knee replacement under spinal anesthesia

Exclusion criteria

* contraindication to spinal anesthesia * allergies to any study drug

Design outcomes

Primary

Measure	Time frame
Controller performance	1 year

Secondary

Measure	Time frame	Description
fluid management	end of surgery	fluid management manual versus guided

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026