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

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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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Ketamine group	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	25 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, 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
Study Start Date :	August 2010
Actual Primary Completion Date :	May 2012
Actual Study Completion Date :	May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 64 Years (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01250418

Locations

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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

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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.

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Responsible Party:	Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier:	NCT01250418
Other Study ID Numbers:	STU00031783
First Posted:	November 30, 2010 Key Record Dates
Results First Posted:	August 28, 2014
Last Update Posted:	August 28, 2014
Last Verified:	August 2014

Keywords provided by Gildasio De Oliveira, Northwestern University:


Bispectral Index Ketamine

Additional relevant MeSH terms:

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Ketamine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anesthetics, Dissociative Anesthetics, Intravenous	Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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