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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01250418
First received: August 3, 2010
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Pain
Drug: Ketamine group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Correlation between OAA/S and BIS and SNAP II index monitors [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    Correlation between OAA/S and BIS and SNAP II index monitors will be evaluated intraoperatively


Enrollment: 20
Study Start Date: August 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ketamine Group
ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
Drug: Ketamine group
ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
No Intervention: No ketamine
No ketamine added to anesthesia regimen

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250418

Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Gildasio DeOliveira, MD Northwestern University
  More Information

Publications:

Responsible Party: Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01250418     History of Changes
Other Study ID Numbers: STU00031783
Study First Received: August 3, 2010
Last Updated: October 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Bispectral Index
Ketamine

Additional relevant MeSH terms:
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014