Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia

Thomas Hemmerling

Status and phase: Completed; Phase 4

Conditions: Conscious Sedation

Treatments: Drug: controlled administration of propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01020643

09-168-GEN

Details and patient eligibility

About

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.

Enrollment: 203 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing hip or knee replacement under spinal anesthesia

Exclusion criteria

• contraindication to spinal anesthesia
• allergies to any study drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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203 participants in 1 patient group

controlled sedation using propofol

Experimental group

Treatment:

Drug: controlled administration of propofol