The Effect of Ketamine on the WAVCNS Index During General Anesthesia: A Feasibility Study

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Monitoring the brain using electroencephalography (EEG) during general anesthesia provides the anesthesiologist with valuable feedback of how deeply anesthetized their patient is, reducing the chances of under- or overdosing and potentially improving patient outcomes. However, commercial EEG monitors that output processed EEG (pEEG) were developed under carefully controlled, simple anesthetic regimes - in contrast to the multimodal "cocktail" of drugs often used in clinical practice. Ketamine is one potential adjunct to a standard anesthetic, which has a growing body of evidence suggesting that it may improve post-operative outcomes. The effects of ketamine on pEEG parameters are poorly understood. This randomized, open-label, feasibility study will be undertaken in a sample of 30 adult outpatient surgery patients. The primary objective is to observe the intra-operative raw and pEEG trends using the NeuroSENSE monitoring system in patients receiving one of two different analgesic doses of ketamine, compared to patients not receiving ketamine, during an otherwise comparable general anesthetic. Secondarily, we will consider other clinical data of interest from both intra- and post-operative contexts in order to establish a broader understanding of the potential influence of two analgesic ketamine doses on anesthetic depth and post-operative outcomes. Feasibility outcomes will be assessed with the ultimate goal of developing a larger-scale clinical trial.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fraser Health
• Collaborator: University of British Columbia
• Treatments: Anesthetics; Ketamine

Criteria

Inclusion Criteria:

• Age 18-54

• ASA I-II

• BMI 15-45

• Elective ACL repair surgery requiring general anesthesia, scheduled to take >60min

• Ability to read and understand the informed consent form

Exclusion Criteria

• Contraindications to ketamine use (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; Abnormality in any previous EEG examination EEG (seizure disorder); Cognitive deficits (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)

• Pre-operative sedative medication (e.g. midazolam) required

• 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