drugset / Trial / NCT03399019
Bispectral Index(BIS) on Depth of Sedation With Dexmedetomidine, Propofol and Midazolam During Spinal Anesthesia
RandomizedParallel-groupTriple-blindOther
Summary
This study is to investigate on the objective relevance between bispectral index (BIS) and Observer's assessment of alertness/sedation (OAA/S) scale in patients sedated with Midazolam, propofol and dexmedetomidine during spinal anesthesia. Also, we will evaluate the reflection of actual sedation levels on BIS monitoring.
Timeline
- Start
- 2016-09-05
- Primary completion
- 2018-03-01
- Completion
- 2018-03-31
Publications
- Background Kato T, Koitabashi T, Ouchi T, Serita R. The utility of bispectral index monitoring for sedated patients treated with low-dose remifentanil. J Clin Monit Comput. 2012 Dec;26(6):459-63. doi: 10.1007/s10877-012-9379-4. Epub 2012 Jul 25.
- Background Venn RM, Grounds RM. Comparison between dexmedetomidine and propofol for sedation in the intensive care unit: patient and clinician perceptions. Br J Anaesth. 2001 Nov;87(5):684-90. doi: 10.1093/bja/87.5.684.
- Background Kasuya Y, Govinda R, Rauch S, Mascha EJ, Sessler DI, Turan A. The correlation between bispectral index and observational sedation scale in volunteers sedated with dexmedetomidine and propofol. Anesth Analg. 2009 Dec;109(6):1811-5. doi: 10.1213/ANE.0b013e3181c04e58.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 0.2 ug/kg | — |
| Subject | Dexmedetomidine | Other / unclassified | 0.7 ug/kg | — |
| Comparator | Midazolam | Small molecule | 0.01 mg/kg | — |
| Comparator | Midazolam | Small molecule | 0.05 mg/kg | — |
| Comparator | Propofol | Small molecule | 0.75 mg/kg | — |
| Comparator | Propofol | Small molecule | 3 mg/kg | — |
Indications
No indication recorded.