Closed-loop Control of Anesthesia: Controlled Delivery of Remifentanil and Propofol

NCT01771263 | Completed

• 1 other identifier: FHREB 2012-056
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

In closed-loop controlled anesthesia, feedback from a measure of the clinical effect is used to continuously adjust drug infusion rates. Anesthetic drugs are delivered at a variable rate that is personalized to the individual patient. The aim is to provide greater hemodynamic and respiratory stability, more stable depth of anesthesia, the ability to predict recovery and to administer a lower total dose of drug. Previous work in closed-loop control of intravenous anesthesia has focused on the titration of propofol in response to a depth of hypnosis (DOH) measure derived from the electroencephalogram (EEG). The purpose of this pilot study is to evaluate iControl-RP, a system, which performs controlled delivery of both remifentanil and propofol infusions. iControl-RP allows either drug to be operated in any of 3 modes: closed-loop control based on feedback from an EEG measure supplied by NeuroSENSE (1); target-controlled infusion (TCI), based on previously-described pharmacokinetic (PK) and pharmacodynamic (PD) models; and conventional manual infusion, which require a weight-based dose setting. A pilot two-phase study will be undertaken in a group of adult patients under the direct and immediate supervision of an experienced anesthesiologist. In Phase 1 (involving 50 study subjects), propofol will be administered in closed-loop mode and a remifentanil infusion will be administered based on a TCI. The data collected in this phase will be used to tune the controller parameters, which are initially based on previously published PKPD data. The controller performance will then be evaluated in phase 2 (involving 100 study subjects), in which both propofol and remifentanil will be administered in closed loop mode. In both phases, cases will be selected from those receiving propofol and remifentanil as anesthetic agents for routine surgical procedures. The investigators aim to demonstrate that closed-loop control of anesthesia and analgesia based on EEG feedback is clinically feasible. This pilot study will help us take a significant step towards a controlled trial in which the clinical benefit of this method of closed-loop control of anesthesia can be assessed.

Conditions

Anesthesia

Keywords

Anesthesia; Propofol; Remifentanil; NeuroSENSE

Outcome Measures

Primary Outcomes (1)

• Depth of Hypnosis (WAVcns)

  Depth of hypnosis measurements will be used among other parameters to assess the feasibility of the system for delivery of propofol and remifentanil for anesthesia

  Continually assessed throughout anesthesia

Secondary Outcomes (1)

• Time until induction complete (Tind)

  Beginning of anesthesia

Study Arms (1)

iControl-RP

OTHER

iControl-RP is a system which performs controlled delivery of both remifentanil and propofol infusions.

Device: iControl-RP

Interventions

iControl-RP DEVICE

iControl-RP

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• ASA I-III
• Elective surgical procedures performed in the operating room at Royal Columbian Hospital requiring TIVA
• Ability to provide informed consent

You may not qualify if:

• Contra-indications to the administration of propofol and/or remifentanil:
• propofol is contraindicated in patients with allergies to eggs, egg products, soybeans or soy products; remifentanil is contraindicated in patients with known hypersensitivity to fentanyl analogs.
• Known or suspected neurological disease
• Known abnormality in any previous EEG examination
• Chronic opioid analgesic (more than 10 doses in previous one month) or other sedative drug therapy
• Body Mass Index (BMI) \< 15 or BMI \> 45
• Premedication other than metoclopramide and/or ranitidine required
• Currently enrolled in another drug or device clinical trial

Sponsors & Collaborators

• Fraser Health: lead

Study Sites (1)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Related Publications (1)

• West N, van Heusden K, Gorges M, Brodie S, Rollinson A, Petersen CL, Dumont GA, Ansermino JM, Merchant RN. Design and Evaluation of a Closed-Loop Anesthesia System With Robust Control and Safety System. Anesth Analg. 2018 Oct;127(4):883-894. doi: 10.1213/ANE.0000000000002663.

  PMID: 29210791 DERIVED

Related Links

• UBC's Pediatric Anesthesia Research Team

Study Officials

• Richard Merchant

  Royal Columbian Hospital and University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 18, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 24, 2016

Record last verified: 2014-08

Locations

CA (1)