SNAP VS BIS(OAA/S) Scale During a Sedation Regimen With and Without Ketamine

Ketamine

Brief Summary

The study question: Does the SNAP-Index (SI) correlates better with the OASS than the BIS Monitor during sedation with ketamine? The study hypothesis: Since the SNAP II monitor seems to be more responsive during emergence of anesthesia, it will have a better correlation with the OASS than the BIS monitor with the use of ketamine.

Intervention / Treatment

  • Ketamine group (DRUG)
    ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.

Condition or Disease

  • Pain

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years to 64 Years
    Enrollment: 25 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Basic Science

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Aug 01, 2010
    Primary Completion: May 01, 2012 ACTUAL
    Completion Date: May 01, 2012 ACTUAL
    Study First Posted: Nov 30, 2010 ESTIMATED
    Results First Posted: Aug 28, 2014 ESTIMATED
    Last Updated: Aug 18, 2014

    Sponsors / Collaborators

    Lead Sponsor: Northwestern University
    Responsible Party: N/A

    Location

    Chicago, Illinois, USA

    Participant Groups

    • ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.

    • No ketamine added to anesthesia regimen

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Maximum Age: 64
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Age : 18-64 years
    * ASA : I-III
    * Procedure : Breast or gynecological surgery
    * Anesthesia :Monitored anesthesia care

    Exclusion Criteria:

    * Pregnancy
    * Breast Feeding
    * Body Mass Index \>35kg/m2
    * Drug or Alcohol abuse
    * Use anticonvulsants
    * History of CVA
    * Drop-out criteria:

    * Patient or surgeon request
    * Conversion to general anesthesia
    * Inability to obtain data from both monitors

    Primary Outcomes

    • % Time Tosca Monitor (TcCO2) above 50. A TcCo2 above 50 is indicative of hypoventilation.

    More Details

    NCT Number: NCT01250418
    Other IDs: STU00031783
    Study URL: https://clinicaltrials.gov/study/NCT01250418
    Last updated: Sep 29, 2023