Effect of Remimazolam on the Recovery Quality After Day Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Remimazolam Induction on the Recovery Quality After Day Surgery in Elderly Patients: a Comparison Study With Etomidate

Conditions
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Elderly Patients, Ambulatory Surgery

Intervention / Treatment
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* Drug: Remimazolam besylate
* Drug: etomidate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing day surgery under laryngeal mask anesthesia American society of anesthesiologists (ASA) grade 1-3 BMI<30kg/m2 Exclusion Criteria: have benzodiazepines drugs in the latest month cognitive dysfunction Cognitive dysfunction and neuropsychiatric disorders It was estimated as a difficult airway There was a history of adrenal insufficiency, porphyria, or chronic corticosteroid therapy There is a contraindication or allergy to benzodiazepines, opioids, etomidate and its components

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: remimazolam<br>remimazolam induction | Drug: Remimazolam besylate<br>* Using remimazolam for induction of general anesthesia<br>|
| Active Comparator: etomidate<br>etomidate induction | Drug: etomidate<br>* Using etomidate for induction of general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |