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

Phase 4

Recruiting

• Conditions: Effect of Drug
• Interventions: Drug: Remimazolam

• Registration Number: NCT06333145
• Lead Sponsor: Tongji Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2024-02-04
• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-03-20
• Study First Posted: 2024-03-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 165

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
obese group	Remimazolam	BMI: ≥30
normal group	Remimazolam	BMI: ≥18.5 and \<24
overweight group	Remimazolam	BMI: ≥24 and \<30

Primary Outcome Measures

Name	Time	Method
Ramsey Sedation Scale	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Time records	1 day	Anesthesia time, induction time, surgical time, awakening time and recovery time
Use of drugs	1 day	The total amount of sedative and analgesic drugs used.
Incidence of PACU Adverse Reactions	1 day	Nausea and vomiting, pain (VAS score), hypotension, bradycardia, dizziness;
Incidence of Treatment-Emergent Adverse Events	2 days	Intraoperative blood pressure and heart rate changes: record the patient's intraoperative blood pressure, heart rate, and the use of related vasoactive drugs; Postoperative adverse reactions: such as hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness, etc.
Respiratory suppression incidence	1 day	Respiratory frequency\<8 times/min or SP02\<90%

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China