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The goal of this clinical trial is to compare remimazolam and etomidate in inducing quality of recovery after day surgery for laryngeal mask general anesthesia in elderly patients. The main question it aims to answer is:
• The quality of postoperative recovery induced by remimazolam for laryngeal mask general anesthesia in elderly patients undergoing day surgery is not inferior to that induced by etomidate Participants will be given remimazolam to induce anesthesia。 Researchers will compare etomidate to see if the quality of postoperative recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| remimazolam | Experimental | remimazolam induction |
|
| etomidate | Active Comparator | etomidate induction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam besylate | Drug | Using remimazolam for induction of general anesthesia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The quality of recovery 15 | The main goal of this study was to assess the QoR using the QoR-15 questionnaire, which is a global measure of recovery after surgery that evaluates five dimensions of recovery: physical comfort (5 items), physical independence (2 items), emotional state (4 items), psychological support (2 items), and pain (2 items). Each item is rated on an 11- point scale based on its frequency on the questionnaire (greater score at greater frequency for positive items and less frequency for negative items). The total score ranged from 0 (poorest recovery quality) to 150 (best recovery quality). | postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| The time of loss of consciousness | The time of disappearance of the eyelash reflex within 3 minutes after the end of the intravenous anesthetic | within 3 minutes after the end of the intravenous anesthetic |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth military medical university, Xijing Hospital | Xi'an | Shannxi | 710032 | China | ||
| Xi 'an International Medical Center Hospital |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2022 | Dec 29, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 29, 2022 | Dec 28, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005045 | Etomidate |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| etomidate |
| Drug |
Using etomidate for induction of general anesthesia |
|
Respiratory, cardiovascular and neurological system adverse events
| During stay of post anesthesia care unit (up to 30minutes） |
| the mean blood pressure，the systolic blood pressure ，the diastolic pressure | Vital signs at different time points | From 5 minutes before anesthesia induction to the time point surgery start |
| heart rate | heart rate at different time points | From 5 minutes before anesthesia induction to the time point surgery start |
| pulse oxygen saturation | pulse oxygen saturation at different time points | From 5 minutes before anesthesia induction to the time point surgery start |
| Xi'an |
| Shannxi |
| 710119 |
| China |
| Yan 'an University Affiliated Hospital | Yanan | Shannxi | 716200 | China |