The Effect of Low Dose Intra-operative Ketamine on Closed-loop Controlled General Anesthesia
Sponsored by NeuroWave Systems Inc.
About This Study
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.
Conditions Studied
Interventions
- •Ketamine Injectable Solution
- •Placebo
Eligibility
View full eligibility 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