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

NCT02492282 | Completed Phase 3 DMC

• 1 other identifier: TIVA-15517889
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, General; Anesthesia, Intravenous

Outcome Measures

Primary Outcomes (1)

• Time in adequate anesthetic depth

  Difference in therapeutic effectiveness determined by the time in state suitable anesthetic depth. The proper anesthetic depth is defined as the efficacy to maintain a Bispectral Index in the range of 40 - 60 during a surgery.

  intraoperative

Secondary Outcomes (9)

• Proportion of patients with adequate anesthetic depth

  intraoperative

• Difference in technical performance drivers intravenous infusion

  intraoperative

• Difference in the proportion of patients with adequate intraoperative analgesia

  intraoperative

• Difference in the proportion of patients in which they have to perform manual modification of the drug infusion.

  intraoperative

• Difference in the rate of change of an intravenous anesthetic technique to a technique based on halogenated.

  intraoperative

Study Arms (2)

Closed-Loop

EXPERIMENTAL

This group includes patients with randomization process be assigned to closed loop intravenous anesthesia; the system evaluates, feeds and acts according to the patient's bispectral index, excluding the anesthesiologist. This system use a variable control of specific therapeutic effect; a target value for this variable (set point); an actuator control (infusion pump), a system (patient) and a control algorithm.

Device: Closed-Loop propofol and remifentanil system by Bispectral Index; Drug: propofol

Open-Loop

ACTIVE COMPARATOR

This group includes patients with the randomization process are assigned to open loop in which the application of anesthetics is exclusively with pharmacokinetic parameters using TCI and employs mathematical models drug. For propofol used Schneider model and Minto model for remifentanil based on effective site concentration. Changes will be made by the anesthesiologist according to his criteria, trying to keep the BIS range of 40 and 60.

Device: Open-Loop propofol and remifentanil by Target Controlled Infusion; Drug: propofol

Interventions

Closed-Loop propofol and remifentanil system by Bispectral Index DEVICE

Closed-Loop

Open-Loop propofol and remifentanil by Target Controlled Infusion DEVICE

Open-Loop

propofol DRUG

Closed-Loop; Open-Loop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (1)

Hospital Universitario San Vicente Fundación

Medellín, Antioquia, Colombia

Location

Related Publications (9)

• Carregal A, Lorenzo A, Taboada JA, Barreiro JL. [Intraoperative control of mean arterial pressure and heart rate with alfentanyl with fuzzy logic]. Rev Esp Anestesiol Reanim. 2000 Mar;47(3):108-13. Spanish.

  PMID: 10800361 BACKGROUND

• Ngan Kee WD, Khaw KS, Ng FF, Tam YH. Randomized comparison of closed-loop feedback computer-controlled with manual-controlled infusion of phenylephrine for maintaining arterial pressure during spinal anaesthesia for caesarean delivery. Br J Anaesth. 2013 Jan;110(1):59-65. doi: 10.1093/bja/aes339. Epub 2012 Sep 25.

  PMID: 23015618 RESULT

• Janda M, Simanski O, Bajorat J, Pohl B, Noeldge-Schomburg GF, Hofmockel R. Clinical evaluation of a simultaneous closed-loop anaesthesia control system for depth of anaesthesia and neuromuscular blockade*. Anaesthesia. 2011 Dec;66(12):1112-20. doi: 10.1111/j.1365-2044.2011.06875.x. Epub 2011 Sep 23.

  PMID: 21950720 RESULT

• Liu N, Chazot T, Trillat B, Pirracchio R, Law-Koune JD, Barvais L, Fischler M. Feasibility of closed-loop titration of propofol guided by the Bispectral Index for general anaesthesia induction: a prospective randomized study. Eur J Anaesthesiol. 2006 Jun;23(6):465-9. doi: 10.1017/S0265021506000196.

  PMID: 16672092 RESULT

• Sakai T, Matsuki A, White PF, Giesecke AH. Use of an EEG-bispectral closed-loop delivery system for administering propofol. Acta Anaesthesiol Scand. 2000 Sep;44(8):1007-10. doi: 10.1034/j.1399-6576.2000.440819.x.

  PMID: 10981581 RESULT

• De Smet T, Struys MM, Neckebroek MM, Van den Hauwe K, Bonte S, Mortier EP. The accuracy and clinical feasibility of a new bayesian-based closed-loop control system for propofol administration using the bispectral index as a controlled variable. Anesth Analg. 2008 Oct;107(4):1200-10. doi: 10.1213/ane.0b013e31817bd1a6.

  PMID: 18806028 RESULT

• Puri GD, Kumar B, Aveek J. Closed-loop anaesthesia delivery system (CLADS) using bispectral index: a performance assessment study. Anaesth Intensive Care. 2007 Jun;35(3):357-62. doi: 10.1177/0310057X0703500306.

  PMID: 17591128 RESULT

• Struys MM, De Smet T, Versichelen LF, Van De Velde S, Van den Broecke R, Mortier EP. Comparison of closed-loop controlled administration of propofol using Bispectral Index as the controlled variable versus "standard practice" controlled administration. Anesthesiology. 2001 Jul;95(1):6-17. doi: 10.1097/00000542-200107000-00007.

  PMID: 11465585 RESULT

• Hemmerling TM, Arbeid E, Wehbe M, Cyr S, Taddei R, Zaouter C. Evaluation of a novel closed-loop total intravenous anaesthesia drug delivery system: a randomized controlled trial. Br J Anaesth. 2013 Jun;110(6):1031-9. doi: 10.1093/bja/aet001. Epub 2013 Feb 20.

  PMID: 23427212 RESULT

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Fabian Casas, MD, Ms

  Universidad de Antioquia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ms.

Study Record Dates

• First Submitted: July 4, 2015
• First Posted: July 8, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: June 20, 2016

Record last verified: 2016-06

Locations

CO (1)