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

The 90% Effective Dose (ED90) of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscope in Adult: an up and Down Sequential Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06333145

Enrollment

165

Registered

2024-03-27

Start date

2024-02-04

Completion date

2026-06-20

Last updated

2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of Drug

Keywords

Drug-induced Sleep Endoscopy, remimazolam, ED90

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.

Interventions

DRUGRemimazolam

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
Respiratory suppression incidence	1 day	Respiratory frequency\<8 times/min or SP02\<90%
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.
Incidence of PACU Adverse Reactions	1 day	Nausea and vomiting, pain (VAS score), hypotension, bradycardia, dizziness;

Countries

China

Contacts

STUDY_CHAIRAihua Du, Dr

Tongji Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026