Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT01250418
Recruitment Status : Terminated (Monitor manufacturer stopped marketing plan for the product.)
First Posted : November 30, 2010
Results First Posted : August 28, 2014
Last Update Posted : August 28, 2014
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University

Tracking Information
First Submitted Date  ICMJE August 3, 2010
First Posted Date  ICMJE November 30, 2010
Results First Submitted Date  ICMJE July 23, 2014
Results First Posted Date  ICMJE August 28, 2014
Last Update Posted Date August 28, 2014
Study Start Date  ICMJE August 2010
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
TcCO2 Above 50 [ Time Frame: Intraoperative, an average of about 1 and 1/2 hours. ]
% Time Tosca Monitor (TcCO2) above 50. A TcCo2 above 50 is indicative of hypoventilation.
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2010)
Correlation between OAA/S and BIS and SNAP II index monitors [ Time Frame: intraoperative ]
Correlation between OAA/S and BIS and SNAP II index monitors will be evaluated intraoperatively
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SNAP VS BIS(OAA/S) Scale During a Sedation Regimen With and Without Ketamine
Official Title  ICMJE A Comparison Between the Correlation of the Bispectral Index Versus Snap Index With the Observer's Assessment of Alertness and Sedation (OAA/S) Scale During a Sedation Regimen With and Without 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Pain
Intervention  ICMJE Drug: Ketamine group
ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
Study Arms  ICMJE
  • Active Comparator: Ketamine Group
    ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
    Intervention: Drug: Ketamine group
  • No Intervention: No ketamine
    No ketamine added to anesthesia regimen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 18, 2014)
25
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2010)
54
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01250418
Other Study ID Numbers  ICMJE STU00031783
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gildasio De Oliveira, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gildasio DeOliveira, MD Northwestern University
PRS Account Northwestern University
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP