Anesthesia Clinical Trial
— iControl-RPOfficial title:
Closed-loop Control of Anesthesia: Controlled Delivery of Remifentanil and Propofol
Verified date | August 2014 |
Source | Fraser Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Royal Columbian Hospital | New Westminster | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Fraser Health |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Time until induction complete (Tind) | Time interval between propofol infusion commencing and the depth of hypnosis remaining below 60 WAVcns units for more than 30 seconds | Beginning of anesthesia | No |
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