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

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ClinicalTrials.gov Identifier: NCT01771263
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : August 24, 2016
Information provided by (Responsible Party):
Fraser Health

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.

Condition or disease Intervention/treatment Phase
Anesthesia Device: iControl-RP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Closed-loop Control of Anesthesia: Controlled Delivery of Remifentanil and Propofol
Study Start Date : February 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
iControl-RP is a system which performs controlled delivery of both remifentanil and propofol infusions.
Device: iControl-RP

Primary Outcome Measures :
  1. Depth of Hypnosis (WAVcns) [ Time Frame: Continually assessed throughout anesthesia ]
    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 :
  1. Time until induction complete (Tind) [ Time Frame: Beginning of anesthesia ]
    Time interval between propofol infusion commencing and the depth of hypnosis remaining below 60 WAVcns units for more than 30 seconds

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 19 years of age or older
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771263

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Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Sponsors and Collaborators
Fraser Health
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Principal Investigator: Richard Merchant Royal Columbian Hospital and University of British Columbia
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fraser Health
ClinicalTrials.gov Identifier: NCT01771263    
Other Study ID Numbers: FHREB 2012-056
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2014
Keywords provided by Fraser Health: