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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
iControl-RP is a system which performs controlled delivery of both remifentanil and propofol infusions.
- 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
- 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
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
|Canada, British Columbia|
|Royal Columbian Hospital|
|New Westminster, British Columbia, Canada, V3L 3W7|
|Principal Investigator:||Richard Merchant||Royal Columbian Hospital and University of British Columbia|