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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03009409
• Date of registration: 29/12/2016
• Prospective Registration: Yes
• Primary sponsor: NeuroWave Systems Inc.
• Public title: The Effect of Low Dose Intra-operative Ketamine on Closed-loop Controlled General Anesthesia
• Scientific title: The Effect of Low Dose Intra-operative Ketamine on Closed-loop Controlled General Anesthesia
• Date of first enrolment: March 13, 2018
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03009409
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Canada

Contacts

• Name: Richard Merchant, MD FRCPC
• Affiliation: Fraser Health

Key inclusion & exclusion 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



Age minimum: 19 Years
Age maximum: 54 Years
Gender: All

Health Condition(s) or Problem(s) studied

Anesthesia

Intervention(s)

Drug: Ketamine Injectable Solution

Other: Placebo

Primary Outcome(s)

Controller performance [Time Frame: Through study completion, an average of 1 year]

Secondary Outcome(s)

Number of participants experiencing shivering in PACU [Time Frame: Through study completion, an average of 1 year]

Number of participants experiencing PONV [Time Frame: Through study completion, an average of 1 year]

Vital signs [Time Frame: Through study completion, an average of 1 year]

Post-operative pain intensity [Time Frame: Through study completion, an average of 1 year]

Propofol consumption [Time Frame: Through study completion, an average of 1 year]

Number of unwanted intra-operative events [Time Frame: Through study completion, an average of 1 year]

Remifentanil consumption [Time Frame: Through study completion, an average of 1 year]

Secondary ID(s)

925-0702-DCI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fraser Health

Office of Naval Research (ONR)