Closed-loop Control of Anesthesia: Controlled Delivery of Remifentanil and Propofol (iControl-RP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Fraser Health
Sponsor:
Information provided by (Responsible Party):
Fraser Health
ClinicalTrials.gov Identifier:
NCT01771263
First received: January 15, 2013
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Anesthesia
Device: iControl-RP

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Closed-loop Control of Anesthesia: Controlled Delivery of Remifentanil and Propofol

Resource links provided by NLM:


Further study details as provided by Fraser Health:

Primary Outcome Measures:
  • Depth of Hypnosis (WAVcns) [ Time Frame: Continually assessed throughout anesthesia ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Time until induction complete (Tind) [ Time Frame: Beginning of anesthesia ] [ Designated as safety issue: No ]
    Time interval between propofol infusion commencing and the depth of hypnosis remaining below 60 WAVcns units for more than 30 seconds


Estimated Enrollment: 150
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
iControl-RP
iControl-RP is a system which performs controlled delivery of both remifentanil and propofol infusions.
Device: iControl-RP

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 19 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771263

Contacts
Contact: Aryannah Umedaly 604-875-2345 ext 5926 aryannah.umedaly@cw.bc.ca
Contact: Nicholas West 604-875-2345 ext 5319 nicholas.west@cw.bc.ca

Locations
Canada, British Columbia
Royal Columbian Hospital Recruiting
New Westminster, British Columbia, Canada, V3L 3W7
Principal Investigator: Richard Merchant         
Sub-Investigator: Mark Ansermino         
Sub-Investigator: Guy A Dumont         
Sub-Investigator: Cedric Ho         
Sub-Investigator: Martin Roos         
Sub-Investigator: Klaske van Heusden         
Sub-Investigator: Christian L Petersen         
Sub-Investigator: Aryannah Umedaly         
Sub-Investigator: Nicholas West         
Sponsors and Collaborators
Fraser Health
Investigators
Principal Investigator: Richard Merchant Royal Columbian Hospital and University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: Fraser Health
ClinicalTrials.gov Identifier: NCT01771263     History of Changes
Other Study ID Numbers: FHREB 2012-056
Study First Received: January 15, 2013
Last Updated: August 5, 2014
Health Authority: Canada: Health Canada

Keywords provided by Fraser Health:
Anesthesia
Propofol
Remifentanil
NeuroSENSE

Additional relevant MeSH terms:
Anesthetics
Propofol
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014