Clinical trial NCT01250418: SNAP VS BIS(OAA/S) Scale During a Sedation Regimen With and Without Ketamine
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Keywords: Bispectral Index
Ketamine
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: TcCO2 Above 50
timeFrame: Intraoperative, an average of about 1 and 1/2 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Gildasio DeOliveira, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.