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A large amount of clinical evidence shows that after surgery, especially major surgery, the sleep quality of patients often drops significantly immediately, with the most obvious decline on the first night after surgery, which can last for several days to several months. Remimazolam is a new type of benzodiazepine drug and a super-short-acting GABAA receptor agonist. Compared with propofol, remimazolam can largely avoid adverse reactions such as hemodynamic fluctuations, excessive sedation and injection pain caused by propofol. It has good safety and is superior to propofol. However, there are currently only a few clinical research results regarding the impact of remimazolam on the sleep quality of patients under general anesthesia or sedation. Therefore, this study intends to observe the effect of remimazolam on the sleep quality of patients in gynecological day surgery. It is expected that by optimizing the anesthesia plan, the postoperative sleep quality of patients can be improved, and ultimately the postoperative recovery of patients can be promoted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam Grop | Experimental | Remimazolam 0.3mg/kg for induction and 0.6-1.0 mg/kg·h for maintenance of anesthesia |
|
| Propofol Group | Active Comparator | Propofol 2 mg/kg for induction and 4-12 mg/kg·h for maintenance of anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | Remimazolam 0.3 mg/kg is slowly injected intravenously until loss of consciousness. Remimazolam 0.6-1.0 mg/kg·h is used for anesthesia maintenance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Richard Campbell's Sleep Scale score | Range: 0 points (optimal sleep) to 10 points (optimal sleep). Direction: The higher the score, the more severe the sleep problem | The night of the first to third postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Before anesthesia, before the insertion of the laryngeal mask, at the beginning of the operation, at the end of the operation, and when the laryngeal mask is removed | |
| Heart rate | Before anesthesia, before the insertion of the laryngeal mask, at the beginning of the operation, at the end of the operation, and when the laryngeal mask is removed. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | Propofol 2 mg/kg is slowly injected intravenously until loss of consciousness. Remimazolam 4-12 mg/kg·h is used for anesthesia maintenance |
|
| Postoperative adverse reactions | such as postoperative pain, nausea, vomiting, and fatigue. | 24 hours after the operation |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |