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

Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01250418
• Other study ID #: STU00031783
• Status: Terminated
• Phase: N/A
• First received: August 3, 2010
• Last updated: August 18, 2014
• Start date: August 2010
• Est. completion date: May 2012

Study information

• Verified date: August 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Ketamine group
ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & 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. — View 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. Epub 2004 Sep 17. — View 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. — View 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. — View 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. — View Citation

Sigl JC, Chamoun NG. An introduction to bispectral analysis for the electroencephalogram. J Clin Monit. 1994 Nov;10(6):392-404. — View 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. — View 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. Epub 2006 May 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No