Effect of Remimazolam on the Recovery Quality After Day Surgery

Not Applicable

Completed

• Conditions: Ambulatory Surgery; Elderly Patients
• Interventions: Drug: Remimazolam besylate; Drug: etomidate

• Registration Number: NCT05748665
• Lead Sponsor: Xijing Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-02-18
• Study First Posted: 2023-03-01
• Study Start: 2023-08-14
• Status Verified: 2024-01
• Primary Completion: 2024-01-24
• Study Completion: 2024-01-26
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
remimazolam	Remimazolam besylate	remimazolam induction
etomidate	etomidate	etomidate induction

Primary Outcome Measures

Name	Time	Method
The quality of recovery 15	postoperative day 1	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).

Secondary Outcome Measures

Name	Time	Method
The time of loss of consciousness	within 3 minutes after the end of the intravenous anesthetic	The time of disappearance of the eyelash reflex within 3 minutes after the end of the intravenous anesthetic
pulse oxygen saturation	From 5 minutes before anesthesia induction to the time point surgery start	pulse oxygen saturation at different time points
Adverse events	During stay of post anesthesia care unit (up to 30minutes）	Respiratory, cardiovascular and neurological system adverse events
the mean blood pressure，the systolic blood pressure ，the diastolic pressure	From 5 minutes before anesthesia induction to the time point surgery start	Vital signs at different time points
heart rate	From 5 minutes before anesthesia induction to the time point surgery start	heart rate at different time points

Trial Locations

Locations (3)

Yan 'an University Affiliated Hospital; 🇨🇳 Yanan, Shannxi, China

The Fourth military medical university, Xijing Hospital; 🇨🇳 Xi'an, Shannxi, China

Xi 'an International Medical Center Hospital; 🇨🇳 Xi'an, Shannxi, China