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

NCT02908945 | Completed

• 1 other identifier: FHREB 2016-054
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia

Keywords

Ketamine; Anesthesia; EEG; NeuroSENSE; Pain

Outcome Measures

Primary Outcomes (1)

• WAVcns

  WAVcns is a measure of depth of hypnosis from the NeuroSENSE monitor.

  Continually assessed throughout general anesthesia during thier surgery, approximately 1-2 hours.

Secondary Outcomes (8)

• Total postoperative cumulative opioid requirements

  During post-anesthesia care unit (PACU) stay, approximately 1-6 hours.

• Occurrence and severity of pain

  At least hourly during post-anesthesia care unit (PACU) stay, approximately 1-6 hours.

• Post-operative nausea & vomiting (PONV) - Nausea

  At least hourly during post-anesthesia care unit (PACU) stay, approximately 1-6 hours.

• Post-operative nausea & vomiting (PONV) - Vomiting

  At least hourly during post-anesthesia care unit (PACU) stay, approximately 1-6 hours.

• Post-operative nausea & vomiting (PONV) - Retching

  At least hourly during post-anesthesia care unit (PACU) stay, approximately 1-6 hours.

Study Arms (3)

Group 1

EXPERIMENTAL

Participants randomized to group 1 will receive a 0.5 mg/kg loading dose of racemic ketamine hydrochloride immediately before induction of anesthesia, followed by a continuous 10 mcg/kg/min infusion throughout maintenance of anesthesia, until procedure end (last suture inserted), up to a maximum cumulative dose of 200 mg. Participants will recieve EEG monitoring with the NeuroSENSE monitor.

Drug: Ketamine; Device: NeuroSENSE monitor

Group 2

EXPERIMENTAL

Participants randomized to group 2 will receive a 0.25 mg/kg loading dose of racemic ketamine hydrochloride immediately before induction of anesthesia, followed by a continuous 5 mcg/kg/min infusion throughout maintenance of anesthesia, until procedure end (last suture inserted), up to a maximum cumulative dose of 200 mg. Participants will recieve EEG monitoring with the NeuroSENSE monitor.

Drug: Ketamine; Device: NeuroSENSE monitor

Group 3

OTHER

Participants randomized to the control group will receive an equivalent anesthetic, without the addition of ketamine. Participants will recieve EEG monitoring with the NeuroSENSE monitor.

Device: NeuroSENSE monitor

Interventions

Ketamine DRUG

Bolus dose before induction of anesthesia and infusion during maintenance of anesthesia.

Also known as: Ketalar

Group 1; Group 2

NeuroSENSE monitor DEVICE

NeuroSENSE monitors the brain using electroencephalography (EEG) and produces an index called the WAVCNS. WAVCNS is a measure of depth of hypnosis (DoH).

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fraser Health: lead
• University of British Columbia: collaborator

Study Sites (1)

Fraser Health: Eagle Ridge Hospital

Port Moody, British Columbia, V3H 3W9, Canada

Location

Related Publications (1)

• van Heusden K, Cooke E, Brodie S, West N, Gorges M, Dumont GA, Ansermino JM, Merchant RN. Effect of ketamine on the NeuroSENSE WAVCNS during propofol anesthesia; a randomized feasibility trial. J Clin Monit Comput. 2021 May;35(3):557-567. doi: 10.1007/s10877-020-00511-0. Epub 2020 Apr 19.

  PMID: 32307624 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Richard Merchant

  Fraser Health (Royal Columbian and Eagle Ridge Hospitals) and University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 21, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: June 22, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)