Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02908945
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : June 22, 2017
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
Richard Merchant, Fraser Health

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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Ketamine Device: NeuroSENSE monitor Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Ketamine on the WAVCNS Index During General Anesthesia: A Feasibility Study
Study Start Date : September 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Group 1
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
Bolus dose before induction of anesthesia and infusion during maintenance of anesthesia.
Other Name: Ketalar

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

Experimental: Group 2
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
Bolus dose before induction of anesthesia and infusion during maintenance of anesthesia.
Other Name: Ketalar

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

Group 3
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
NeuroSENSE monitors the brain using electroencephalography (EEG) and produces an index called the WAVCNS. WAVCNS is a measure of depth of hypnosis (DoH).




Primary Outcome Measures :
  1. WAVcns [ Time Frame: Continually assessed throughout general anesthesia during thier surgery, approximately 1-2 hours. ]
    WAVcns is a measure of depth of hypnosis from the NeuroSENSE monitor.


Secondary Outcome Measures :
  1. Total postoperative cumulative opioid requirements [ Time Frame: During post-anesthesia care unit (PACU) stay, approximately 1-6 hours. ]
    All opioid medication will be recorded in the PACU. Will be calculated as morphine equivalent doses.

  2. Occurrence and severity of pain [ Time Frame: At least hourly during post-anesthesia care unit (PACU) stay, approximately 1-6 hours. ]
    Subjects report their pain intensity at rest and upon knee flexion, if possible, using a 0-10 numerical rating scale.

  3. Post-operative nausea & vomiting (PONV) - Nausea [ Time Frame: At least hourly during post-anesthesia care unit (PACU) stay, approximately 1-6 hours. ]
    Nausea is defined as the subjective report of upset stomach or urge to vomit, and will be measured using a self-reported numerical rating scale from 0 (no nausea) to 10 (the worst nausea imaginable) hourly or more frequently if needed. Standard nursing records will include any reports of post-operative nausea.

  4. Post-operative nausea & vomiting (PONV) - Vomiting [ Time Frame: At least hourly during post-anesthesia care unit (PACU) stay, approximately 1-6 hours. ]
    Vomiting is defined as the forcible ejection of stomach contents through the mouth. Standard nursing records will include any reports of post-operative vomiting.

  5. Post-operative nausea & vomiting (PONV) - Retching [ Time Frame: At least hourly during post-anesthesia care unit (PACU) stay, approximately 1-6 hours. ]
    Retching is defined as gastric and esophageal movements of vomiting without expulsion of vomitus. Standard nursing records will include any reports of post-operative retching.

  6. Post-operative nausea & vomiting (PONV) - Anti-emetic medication [ Time Frame: At least hourly during post-anesthesia care unit (PACU) stay, approximately 1-6 hours. ]
    Standard nursing records will include the dose and time of any anti-emetic medication given.

  7. Postoperative shivering [ Time Frame: Admission to post-anesthesia care unit (PACU), and 30 and 60 minutes thereafter during their PACU stay, approximately 1-6 hours. ]
    Shivering is based on a 4 point scale from 0 (no shivering) to 3 (Gross muscular activity involving the entire body)

  8. Dreaming and awareness [ Time Frame: Once subject is oriented to time, place, and person, in the post-anesthesia care unit (PACU). This questionnaire will take from 5-15 minutes to complete. ]
    A standard questionnaire will be administered.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908945


Locations
Layout table for location information
Canada, British Columbia
Fraser Health: Eagle Ridge Hospital
Port Moody, British Columbia, Canada, V3H 3W9
Sponsors and Collaborators
Fraser Health
University of British Columbia
Investigators
Layout table for investigator information
Principal Investigator: Richard Merchant Fraser Health (Royal Columbian and Eagle Ridge Hospitals) and University of British Columbia

Additional Information:
Layout table for additonal information
Responsible Party: Richard Merchant, Anesthesiologist, Fraser Health
ClinicalTrials.gov Identifier: NCT02908945     History of Changes
Other Study ID Numbers: FHREB 2016-054
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Once data collection is complete, a de-identified version of the data may be made available to other researchers. This will be specifically stated in the consent form, and participants will be asked to provide their consent for releasing their anonymized data as well as for participating in the study. Participants may still participate in the study if they do not consent to make their data available.
Keywords provided by Richard Merchant, Fraser Health:
Ketamine
Anesthesia
EEG
NeuroSENSE
Pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Ketamine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action