Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index

Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index: Comparison Between Manual Perfusion and Automated Perfusion

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00393003

Enrollment

Registered

2006-10-26

Start date

2006-09-30

Completion date

2007-04-30

Last updated

2009-08-31

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

Conditions

Postoperative Sedation

Keywords

Anesthesia, Sedation

Brief summary

This prospective randomized study evaluates the effectiveness of a closed-loop anesthesia system during the postoperative period.

Detailed description

The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. A closed-loop anesthesia system can be built using BIS as the control variable, two proportional-integral-differential control algorithms, a propofol and a remifentanil target-controlled infusion systems as the control actuators. Preliminary results show that this system can be used during surgery. We propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system during the postoperative period. Two groups of patients are compared: one in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion systems, and one in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system. In both groups, the goal is to maintain BIS between 40 and 60, the recommended range during anesthesia by the manufacturer. We expect the combined closed-loop system group to do similar or better.

Interventions

DEVICEClosed-loop anesthesia system

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* American Society of Anesthesiologists physical status 1-3 * Abdominal aorta surgery

Exclusion criteria

* Pregnant women * Neurological or muscular disorder

Design outcomes

Primary

Measure	Time frame
Global score (calculated parameter which depicts the performance of the system)	—

Secondary

Measure	Time frame
Consumption of propofol and remifentanil, modifications of target of propofol and remifentanil, dysfunction of each system, hemodynamic abnormalities, sedation scale, volume loading, extubation time, explicit memorisation.	—

Countries

France

Outcome results

None listed

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