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

This study is currently recruiting participants.

Verified April 2013 by Northwestern University

Sponsor:

Information provided by (Responsible Party):

Gildasio De Oliveira, Northwestern University

ClinicalTrials.gov Identifier:

NCT01250418

First received: August 3, 2010

Last updated: April 8, 2013

Last verified: April 2013

History of Changes

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:

Drug Information available for: Ketamine hydrochloride Ketamine

U.S. FDA Resources

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

Estimated Enrollment:	50
Study Start Date:	August 2010
Estimated Primary Completion Date:	April 2013 (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

Contacts

Contact: Gildasio De Oliveira, MD

312-926-8373

Locations

United States, Illinois
Northwestern Memorial Hospital	Recruiting
Chicago, Illinois, United States, 60611
Contact: Gildasio De Oliveira, M.D. 312-926-8373 g-jr@northwestern.edu
Contact: Robert McCarthy, PharmD 312-926-9015 r-mccarthy@northwestern.edu
Principal Investigator: Gildasio De Oliveira, M.D.

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:

Gildasio DeOliveira, MD

Northwestern University

More Information

Publications:

Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51.

Sigl JC, Chamoun NG. An introduction to bispectral analysis for the electroencephalogram. J Clin Monit. 1994 Nov;10(6):392-404.

Glass PS, Bloom M, Kearse L, Rosow C, Sebel P, Manberg P. Bispectral analysis measures sedation and memory effects of propofol, midazolam, isoflurane, and alfentanil in healthy volunteers. Anesthesiology. 1997 Apr;86(4):836-47.

Iselin-Chaves IA, Flaishon R, Sebel PS, Howell S, Gan TJ, Sigl J, Ginsberg B, Glass PS. The effect of the interaction of propofol and alfentanil on recall, loss of consciousness, and the Bispectral Index. Anesth Analg. 1998 Oct;87(4):949-55.

Song D, Joshi GP, White PF. Titration of volatile anesthetics using bispectral index facilitates recovery after ambulatory anesthesia. Anesthesiology. 1997 Oct;87(4):842-8.

Sebel PS, Lang E, Rampil IJ, White PF, Cork R, Jopling M, Smith NT, Glass PS, Manberg P. A multicenter study of bispectral electroencephalogram analysis for monitoring anesthetic effect. Anesth Analg. 1997 Apr;84(4):891-9.

Dressler O, Schneider G, Stockmanns G, Kochs EF. Awareness and the EEG power spectrum: analysis of frequencies. Br J Anaesth. 2004 Dec;93(6):806-9. Epub 2004 Sep 17.

Wong CA, Fragen RJ, Fitzgerald P, McCarthy RJ. A comparison of the SNAP II and BIS XP indices during sevoflurane and nitrous oxide anaesthesia at 1 and 1.5 MAC and at awakening. Br J Anaesth. 2006 Aug;97(2):181-6. Epub 2006 May 23.

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:	April 8, 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 June 13, 2013

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