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

NCT06333145 | Completed Phase 4

• 1 other identifier: EDRA
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Effect of Drug

Keywords

Drug-induced Sleep Endoscopy; remimazolam; ED90

Outcome Measures

Primary Outcomes (1)

• Ramsey Sedation Scale

  Using the Ramsey Sedation Scale scoring table ranging from 1-6 to evaluate if the sedation is successful 1point: Patients are anxious, restless or irritable; 2point: Patients cooperative, well-oriented and quiet; 3point: Patients fall asleep and respond only to commands; 4point: Patients fall asleep and respond quickly to eyebrow taps or loud auditory stimuli; 5point: Patients fall asleep and are blunt to respond to eyebrow taps or loud auditory stimuli; 6point: Patients fall asleep and do not respond to the above stimuli.

  1 day

Secondary Outcomes (5)

• Time records

  1 day

• Use of drugs

  1 day

• Respiratory suppression incidence

  1 day

• Incidence of Treatment-Emergent Adverse Events

  2 days

• Incidence of PACU Adverse Reactions

  1 day

Study Arms (3)

normal group

EXPERIMENTAL

BMI: ≥18.5 and \<24

Drug: Remimazolam

overweight group

EXPERIMENTAL

BMI: ≥24 and \<30

Drug: Remimazolam

obese group

EXPERIMENTAL

BMI: ≥30

Drug: Remimazolam

Interventions

Remimazolam DRUG

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

Also known as: Remimazolam besylate

normal group; obese group; overweight group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Interventions

remimazolam

Study Officials

• Aihua Du, Dr

  Tongji Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: February 4, 2024
• Primary Completion: June 20, 2026
• Study Completion: June 20, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)