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Monitor manufacturer stopped marketing plan for the product.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine Group | Active Comparator | ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min. |
|
| No ketamine | No Intervention | No ketamine added to anesthesia regimen |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine group | Drug | ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy
Breast Feeding
Body Mass Index >35kg/m2
Drug or Alcohol abuse
Use anticonvulsants
History of CVA
Drop-out criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gildasio DeOliveira, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2286697 | Background | 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. | |
| 7836975 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine Group | ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min. |
| FG001 | No Ketamine | No ketamine added to anesthesia regimen |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine Group | ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min. Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min. |
| BG001 | No Ketamine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | TcCO2 Above 50 | % Time Tosca Monitor (TcCO2) above 50. A TcCo2 above 50 is indicative of hypoventilation. | Posted | Mean | Standard Deviation | Percent time intraoperatrive | Intraoperative, an average of about 1 and 1/2 hours. |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Ketamine Added to Anesthesia Regimen | No ketamine added to the patients anesthesia regimen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gildasio De Oliveira MD | Northwestern University | 312-472-3573 | g-jr@northwestern.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 9105228 | 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. |
| 9768800 | 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. |
| 9357886 | 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. |
| 9085977 | 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. |
| 15377585 | 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. |
| 16720676 | 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. |
No ketamine added to anesthesia regimen
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Ketamine Group | Ketamine group: Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min. | 0 | 9 | 0 | 9 |
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