Evaluation of a Novel Closed-loop Propofol and Remifentanil System Guided by Bispectral Index Compared to a TCI Open-loop System

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Closed loop system in intravenous anesthesia is more effective to maintain depth of anesthesia compared with manual system open, it is unclear what driver and variables to achieve this goal be more physiological; in the literature doesn´t exist studies showing that the closed-loop system for both hypnotic and opioid is better than the controlled pharmacokinetic models and open loop system (target controlled infusion-TCI) to maintain anesthetic depth. In addition, the infusion of the opioid lacks physiological controllers in closed loop. Thus, a system was designed for intravenous anesthesia in closed loop for propofol as hypnotic based on neuromonitoring bispectral index as anesthetic depth, and was integrated an additional closed system for remifentanil using hemodynamic variables and control algorithm associated with bispectral index.

The purpose of this study is to determine the therapeutic effectiveness of a new system of administration of intravenous anesthesia in closed loop to maintain a depth of anesthesia compared to an open loop system TCI.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidad de Antioquia
• Treatments: Propofol; Remifentanil

Criteria

Inclusion Criteria:

• Older than 18 years

• Scheduled for noncardiac surgery elective low-risk or intermediate

• Expected surgery time greater than 1 hour

• Procedure requiring general anesthesia

• Classification of the American Society of Anesthesiologists (ASA) as I or II

Exclusion Criteria:

• Pregnant women

• Surgery scheduled urgent or emergency

• Personal history of allergy to eggs or any other part of propofol

• Personal history of abnormalities or congenital or acquired cognitive sequels:

infantile cerebral palsy, Down syndrome, cerebral ischemic disease, traumatic brain injury, brain tumor, autism.

• Chronic use of benzodiazepines or antipsychotics

• A patient who does not consent to participate in the study prior to surgery or before randomization

• Need for anesthetic or analgesic blockade before surgery peripheral nerve