The Effect of Low Dose Intra-operative Ketamine on Closed-loop Controlled General Anesthesia

• Status: Completed
• Trial end date: 2018-10-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NeuroWave Systems Inc.
• Collaborators: Fraser Health; Office of Naval Research (ONR)
• Treatments: Anesthetics; Ketamine

Criteria

Inclusion Criteria:

• Age 19-54

• ASA I-II

• BMI 15-45

• Elective ACL repair surgery requiring general anesthesia

• Ability to read and understand the informed consent form

Exclusion Criteria:

• Contraindications to ketamine use Those in whom a significant elevation of blood pressure would constitute a serious hazard (e.g. severe cardiovascular disease, pacemaker, pheochromocytoma, malignant hypertension, intraocular pressure pathology, acute globe injury, hyperthyroidism)

• Contraindications to propofol Anaphylactic reaction to eggs, egg products, soybeans or soy products

• Contraindications to remifentanil Hypersensitivity to fentanyl analogues

• Known or suspected neurological disease Tumor, stroke, neurodegenerative disease, major head injury, seizure disorder Abnormality in any previous EEG examination Cognitive deficits (e.g. dementia, developmental delay)

• Acquired scalp or skull abnormalities

• Psychiatric illness Severe depression, PTSD, psychosis Any psychotropic medication taken in the past 7 days

• History of drug misuse/abuse within past 30 days Ketamine, cocaine, heroin, amphetamines, phencyclindine, lysergic acid (LSD), mescaline, psilocybin Chronic alcoholism

• Requirement for pre-operative sedative medication (e.g. midazolam) for anxiolysis

• Anticipated intra-operative or pre-operative use of nitrous oxide, catecholamines (dopamine, epinephrine, norepinephrine) or thyroid hormones

• Pregnant or nursing

• Currently enrolled in any other research study involving drugs or devices