Clinical Trials Logo

Clinical Trial Summary

Closed-loop control of anesthesia involves using feedback from a measure of clinical effect to continuously adjust drug infusion rates. As a result, anesthetic drugs are delivered at a variable rate that is frequently personalized to each individual patient. The aim is to provide greater stability at an optimal depth of anesthesia, reducing the occurrence of under- or overdosing, with the goal of ultimately improving patient outcomes.

The purpose of this randomized, controlled equivalence trial is to compare controller performance during closed-loop controlled induction and maintenance of total intravenous anesthesia, using iControl system, with the addition of a low (analgesic) dose of ketamine versus saline control.


Clinical Trial Description

For the primary outcome measure, the investigators hypothesize that controller performance with low-dose ketamine will be equivalent to the controller performance without low-dose ketamine. The primary outcome measure, controller performance, is the percentage of time during the maintenance phase when the depth-of-hypnosis (DOH) measure is within +-10 points of the set point in patients receiving low dose ketamine versus those receiving saline control.

This study will consider other clinical data of interest from both intra- and post-operative contexts in order to establish a broader understanding of the potential implications of the use of a low dose of ketamine during closed-loop controlled anesthesia. In the OR, the investigators will record other indications of anesthetic quality, such as vital signs and the occurrence of any unwanted intra-operative events. Propofol and remifentanil consumption will be quantified, and the requirement of any other interventions will be recorded. The investigators will also record post-operative patient outcomes that have previously been associated with ketamine administration, such as acute post-operative pain intensity, opioid requirements, the occurrence of PONV, and shivering occurring in the post-anesthesia care unit (PACU). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03009409
Study type Interventional
Source NeuroWave Systems Inc.
Contact
Status Completed
Phase Phase 1
Start date March 13, 2018
Completion date October 17, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Recruiting NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Completed NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Suspended NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT04567160 - NOL Index to Compare the Intraoperative Analgesic Effect of Propofol Versus Sevoflurane Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas
Completed NCT04238741 - Audio-recording of Consent for Anaesthesia for Elective Caesarean Section N/A
Completed NCT03294213 - Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScopeā„¢ 4 Broncho and aView
Not yet recruiting NCT03929315 - 3D OLV Training Intervention for Pediatric Anesthesia Trainees
Not yet recruiting NCT04024410 - Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery
Completed NCT02908945 - The Effect of Ketamine on the WAVCNS Index During General Anesthesia: A Feasibility Study N/A