Effect of Remimazolam on the Recovery Quality After Day Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Elderly Patients; Ambulatory Surgery
• Intervention / Treatment: Drug: Remimazolam besylate; Drug: etomidate

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shannxi
    • Xi'an, Shannxi, China, 710032
      • The Fourth Military Medical University, Xijing Hospital
    • Xi'an, Shannxi, China, 710119
      • Xi 'an International Medical Center Hospital
    • Yanan, Shannxi, China, 716200
      • Yan 'an university Affiliated Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: remimazolam; remimazolam induction	Drug: Remimazolam besylate; Using remimazolam for induction of general anesthesia
Active Comparator: etomidate; etomidate induction	Drug: etomidate; Using etomidate for induction of general anesthesia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Actual): January 24, 2024
• Study Completion (Actual): January 26, 2024

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: February 18, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Etomidate
• Other Study ID Numbers: KY20222277-F-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No