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

NCT01250418 | Terminated Results

• 1 other identifier: STU00031783
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Bispectral Index; Ketamine

Outcome Measures

Primary Outcomes (1)

• TcCO2 Above 50

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

  Intraoperative, an average of about 1 and 1/2 hours.

Study Arms (2)

Ketamine Group

ACTIVE COMPARATOR

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

Drug: Ketamine group

No ketamine

NO INTERVENTION

No ketamine added to anesthesia regimen

Interventions

Ketamine group DRUG

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

Ketamine Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (8)

• 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.

  PMID: 2286697 BACKGROUND

• Sigl JC, Chamoun NG. An introduction to bispectral analysis for the electroencephalogram. J Clin Monit. 1994 Nov;10(6):392-404. doi: 10.1007/BF01618421.

  PMID: 7836975 BACKGROUND

• 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. doi: 10.1097/00000542-199704000-00014.

  PMID: 9105228 BACKGROUND

• 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. doi: 10.1097/00000539-199810000-00038.

  PMID: 9768800 BACKGROUND

• 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. doi: 10.1097/00000542-199710000-00018.

  PMID: 9357886 BACKGROUND

• 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. doi: 10.1097/00000539-199704000-00035.

  PMID: 9085977 BACKGROUND

• 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. doi: 10.1093/bja/aeh270. Epub 2004 Sep 17.

  PMID: 15377585 BACKGROUND

• 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. doi: 10.1093/bja/ael131. Epub 2006 May 23.

  PMID: 16720676 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gildasio De Oliveira MD
• Organization: Northwestern University

g-jr@northwestern.edu

312-472-3573

Study Officials

• Gildasio DeOliveira, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gildasio De Oliveira, M.D. Principal Investigator

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: November 30, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 28, 2014
• Results First Posted: August 28, 2014

Record last verified: 2014-08

Locations

US (1)