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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.
Sedation is an important element of regional anesthesia during surgery, which allows to finish surgery smoothly by reducing patients' anxiety and fear who undergo regional and local anesthesia.
If adequate sedation is not maintained during regional anesthesia, surgery may be disturbed by patient's movement. This can cause the patient to be physically and mentally stressed with discomfort.
Commonly used measurement to determine the adequate sedation level relies on subjective physician's assessment such as scoring for response to talk, shake and pain. This measurement is unreliable and not continuous.
Recently, BIS is used to guide sedation during spinal anesthesia as an objective monitoring method in many studies. but previous studies result contrasting in the correlation between BIS and sedation levels with lack in evaluation between sedative drugs.
In this study, the investigators will investigate the usefullness of BIS monitoring during regional anesthesia with sedation and evaluate the suitability of correlation BIS and OAA/S between drugs (midazolam, propofol and dexmedetomidine). The anesthetic and sedation protocol will be standardized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | Dexmedetomidine : initial loading 0.5- 1 mng/kg for 10 minutes and maintenance 0.2-0.7mng/kg/hr Check BIS (bispectral index) score and OAA/S (Observer assessment of alertness/sedation score) by time |
|
| Propofol | Active Comparator | Propofol : 0.75-3 mg/kr/hr continous infusion Check BIS (bispectral index) score and OAA/S (Observer assessment of alertness/sedation score) by time |
|
| Midazolam | Active Comparator | Midazolam : initial loading 0.5- 1 mng/kg for 10 minutes and maintenance 0.2-0.7mng/kg/hr Check BIS (bispectral index) score and OAA/S (Observer assessment of alertness/sedation score) by time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | initial loading dose (0.5 ~ 1㎍/kg for 10 minutes) and maintenance infusion (0.2-0.7㎍/kg/hr) |
|
| Measure | Description | Time Frame |
|---|---|---|
| correlation between BIS and OAA/S (observer's assessment of alertness/sedation) score | Statistically significant (p<0.05) correlations between BIS (range of 0-100) and OAA/S scale (range of 1-5) in dexmedetomidine, propofol and midazolam. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of rescue analgesics (fentanyl in mg) and rescue hypnotic (propofol in mg) | The amount of rescue hypnotics due to insufficient sedation (total additional volume of propofol in mg) and rescue analgesics (total additional volume of fentanyl in mng) due to insufficient pain control | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Hwa Choi, M.D | Contact | +82-31-380-3945 | pcyhchoi@hallym.or.kr | |
| Soo Kyung Lee, M.D | Contact | +82-31-380-3945 | agneta@hallym.or.kr |
| Name | Affiliation | Role |
|---|---|---|
| Soo Kyung Lee, M.D | Hallym University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Recruiting | Anyang-si | Gyeonggi-do | KS009 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22828857 | 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. | |
| 11878517 | 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. |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D015742 | Propofol |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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This study compares to the same intervention (monitor BIS scores and OAA/S scores timely) between all of three sedative drugs.
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| Propofol | Drug | continuous infusion (0.75-3mg/kg/hr) |
|
| Midazolam | Drug | 0.05mg/kg bolus injection and if not OAA/S ≤ 3 within 5 minutes, add 0.01mg/kg at intervals of 1~2 minutes |
|
| 19923507 | 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. |
| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |