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The purpose of this study is to compare the sedation efficacy of dexmedetomidine and remimazolam for intraoperative sedation during regional block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam | Active Comparator |
| |
| Dexmedetomidine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | 0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.5~1.0 mg/kg/h continuous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of rescue sedative doses administered | Intraoperative period |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intraoperative bradycardia (heart rate lower than 45 bpm) | Intraoperative period | |
| Incidence of intraoperative hypotension (mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline) | Intraoperative period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Jongno-gu | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37280081 | Derived | Kim H, Kim Y, Bae J, Yoo S, Lim YJ, Kim JT. Comparison of remimazolam and dexmedetomidine for intraoperative sedation in patients undergoing lower extremity surgery under spinal anesthesia: a randomized clinical trial. Reg Anesth Pain Med. 2024 Feb 5;49(2):110-116. doi: 10.1136/rapm-2023-104415. |
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Dexmedetomidine | Drug | 1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2~0.7 mcg/kg/h continuous infusion |
|
| Incidence of intraoperative hypertension (systolic blood pressure higher than 120% of baseline) | Intraoperative period |
| Incidence of respiratory depression (respiratory rate lower than 8 per minute) | Intraoperative period |
| Incidence of hypoxia (oxygen saturation detected by pulse oxymetry less than 93%) | Intraoperative period |
| MOAA/S score (Modified Observer's Assessment of Alertness and Sedation, 0=unarousable, 5=alert) | Intraoperative period |
| Intraoperative PSi (Patient State index) | Intraoperative period |
| Electroencephalogram data (alpha, beta, delta, theta waves) | Intraoperative period |
| Time to reach MOAA/S = 5 after end of drug infusion | Intraoperative period and post-anesthesia care period (immediate post-operative period) |
| Oxygen supply at the post-anesthesia care unit | Post-anesthesia care period (immediate post-operative period) |
| Incidence of postoperative delirium | Immediately after the surgery, up to 5 days after surgery |
| Incidence of nausea/vomiting | Intraoperative period and post-anesthesia care period (immediate post-operative period) |
| Postoperative spinal anesthesia block level | Postoperative period, up to 12h hours after end of surgery |
| Duration of stay in the post-anesthsia care unit(PACU) | Immediate postoperative period |
| Patient satisfaction (numerical rating scale of 0~10) | 0 Not at all satisfied, 10 very satisfied | Immediately after the surgery, up to 5 days after surgery |
| Serum CRP level | Preoperative baseline and second postoperative day |