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Regional anesthesia is a common clinical anesthesia method, and regional anesthesia-assisted sedation play a central role in promoting patient comfort and relieving anxiety. With increasing age, elderly people experience changes in pharmacokinetics and pharmacodynamics and increased drug sensitivity. Ciprofol has advantages in adverse events such as hypotension and respiratory depression. There are fewer studies on the recommended dosage of ciprofol-assisted sedation for intrathecal anesthesia in elderly patients. The aim of study is to identify the 95% effective dose of ciprofol-assisted sedation in elderly patients undergoing spinal anesthesia using a biased coin design up-and-down sequential method(BCD-UDM)
Select the patients who will receive knee arthroplasty in the Second Hospital of Shanxi Medical University. The patients will receive a loading dosage of 0.05mg/kg of ciprofol to begin sedation following the completion of intravertebral anesthesia, and the maintenance dose is calculated using a biased coin design up-and-down sequential method. Based on the relevant literature and pilot study, 0.2 mg·kg-1·h-1 is selected as initial test dose with a dose gradient of 0.02 mg·kg-1·h-1. The Modified Alertness Sedation Score (MOAA/S ) scores and the bispectral index (BIS) were recorded for patients before administration (T0), 5 min after administration (T1), 10 min after administration (T2), 20 min after administration (T3), 30 min after administration (T4), 45 min after administration (T5), and 60min after administration (T6). If the first patient had ≥ 4 time points with MOAA/A score ≤3 from T0-T6, the sedation was regarded as satisfactory, the dose of next patient is randomly assigned to the next lower dose with 5% probability, or to the same dose with 95% probability; If the previous patient was not satisfactorily sedated, the next patient's infusion dose was increased by 0.02 mg·kg-1·h-1. When the number of satisfied cases of sedation reaches 45, the trial is terminated. At the same time, the change of vital signs and adverse reactions before and after administration were recorded
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ciprofol-assisted sedation 1 | Experimental | Adjusting the dose of ciprofol-assisted sedation in knee arthroplasty on a case-by-case basis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofol | Drug | Ciprofol was injected intravenously, and was pumped during operation to maintain sedation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Alertness Sedation Score (MOAA/S) | Changes in Modified Alertness Sedation Score | 24 hours |
| Bispectral index (BIS) | Changes in Bispectral index | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| systolic blood pressure (SBP) | Changes in systolic blood pressure | 24 hours |
| diastolic blood pressure(DBP) | Changes in diastolic blood pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Sedation-related adverse events | It includes intraoperative and postoperative sedation-related adverse events | 72 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Hospital of Shanxi Medical University | Recruiting | Taiyuan | Shanxi | 030001 | China |
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| ID | Term |
|---|---|
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| 24 hours |
| heart rate (HR) | changes in heart rate | 24 hours |
| pulse oxygen saturation(SpO2) | changes in pulse oxygen saturation | 24 hours |
| D000588 |
| Amines |