Effect of Remimazolam on the Recovery Quality After Day Surgery

NCT05748665 | Completed

• 1 other identifier: KY20222277-F-1
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 3

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.

Conditions

Elderly Patients; Ambulatory Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The time of loss of consciousness

  within 3 minutes after the end of the intravenous anesthetic

• Adverse events

  During stay of post anesthesia care unit (up to 30minutes）

• the mean blood pressure，the systolic blood pressure ，the diastolic pressure

  From 5 minutes before anesthesia induction to the time point surgery start

• heart rate

  From 5 minutes before anesthesia induction to the time point surgery start

• pulse oxygen saturation

  From 5 minutes before anesthesia induction to the time point surgery start

Study Arms (2)

remimazolam

EXPERIMENTAL

remimazolam induction

Drug: Remimazolam besylate

etomidate

ACTIVE COMPARATOR

etomidate induction

Drug: etomidate

Interventions

Remimazolam besylate DRUG

Using remimazolam for induction of general anesthesia

remimazolam

etomidate DRUG

Using etomidate for induction of general anesthesia

etomidate

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing day surgery under laryngeal mask anesthesia
• American society of anesthesiologists (ASA) grade 1-3
• BMI\<30kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (3)

The Fourth military medical university, Xijing Hospital

Xi'an, Shannxi, 710032, China

Location

Xi 'an International Medical Center Hospital

Xi'an, Shannxi, 710119, China

Location

Yan 'an University Affiliated Hospital

Yanan, Shannxi, 716200, China

Location

MeSH Terms

Interventions

Etomidate

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: March 1, 2023
• Study Start: August 14, 2023
• Primary Completion: January 24, 2024
• Study Completion: January 26, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-01

Locations

CN (3)