ED90 of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscopy in Adults

NCT ID: NCT06333145

Last Updated: 2025-05-07

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

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-04

Study Completion Date

2025-12-31

Brief Summary

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Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups.

Detailed Description

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Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups, to provide a more scientific medication scheme for sedation in Drug-induced Sleep Endoscopy.

Conditions

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Effect of Drug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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normal group

BMI: ≥18.5 and \<24

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

Exploring ED90 induced by remimazolam anesthesia in adults of different BMI groups undergoing drug-induced sleep endoscopy

overweight group

BMI: ≥24 and \<30

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

Exploring ED90 induced by remimazolam anesthesia in adults of different BMI groups undergoing drug-induced sleep endoscopy

obese group

BMI: ≥30

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

Exploring ED90 induced by remimazolam anesthesia in adults of different BMI groups undergoing drug-induced sleep endoscopy

Interventions

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Remimazolam

Exploring ED90 induced by remimazolam anesthesia in adults of different BMI groups undergoing drug-induced sleep endoscopy

Intervention Type DRUG

Other Intervention Names

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Remimazolam besylate

Eligibility Criteria

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Inclusion Criteria

* 1\. Age 18-65 years old, 2. ASA Ⅰ-Ⅲ level; 3. Sign an informed consent form.

Exclusion Criteria

* 1.A history of central nervous system diseases, cognitive disorders, mental disorders, or communication disorders; 2.serious cardiovascular, respiratory, liver or kidney disease; 3.Anticipated need for tracheal intubation or laryngeal mask; 4.Allergic to benzodiazepines and opioids; 5.Those who have taken sedative, analgesic or antidepressant drugs within 24 hours; 6.Abnormal liver and kidney function; 7.Recently participated in other clinical studies.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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aijun xu

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aihua Du, Dr

Role: STUDY_CHAIR

Tongji Hospital

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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mujun chang

Role: CONTACT

+862783663625

Facility Contacts

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aijun xu, Dr.

Role: primary

027-83663173

yuan Bi, Dr.

Role: backup

027-18972718216

Other Identifiers

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EDRA

Identifier Type: -

Identifier Source: org_study_id

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