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

NCT02908945 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-06-22

No results posted yet for this study

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

Interventions

DRUG

Ketamine

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

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).

Sponsors & Collaborators

  • University of British Columbia

    collaborator OTHER

  • Fraser Health

    lead OTHER

Principal Investigators

  • Richard Merchant · Fraser Health (Royal Columbian and Eagle Ridge Hospitals) and University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02908945 on ClinicalTrials.gov