Effect of Remimazolam on the Recovery Quality After Day Surgery

NCT ID: NCT05748665

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-14

Study Completion Date

2024-01-26

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.

Detailed Description

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Conditions

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Elderly Patients Ambulatory Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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remimazolam

remimazolam induction

Group Type EXPERIMENTAL

Remimazolam besylate

Intervention Type DRUG

Using remimazolam for induction of general anesthesia

etomidate

etomidate induction

Group Type ACTIVE_COMPARATOR

etomidate

Intervention Type DRUG

Using etomidate for induction of general anesthesia

Interventions

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Remimazolam besylate

Using remimazolam for induction of general anesthesia

Intervention Type DRUG

etomidate

Using etomidate for induction of general anesthesia

Intervention Type DRUG

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Fourth military medical university, Xijing Hospital

Xi'an, Shannxi, China

Site Status

Xi 'an International Medical Center Hospital

Xi'an, Shannxi, China

Site Status

Yan 'an University Affiliated Hospital

Yanan, Shannxi, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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KY20222277-F-1

Identifier Type: -

Identifier Source: org_study_id

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