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

Tongji Hospital

Status and phase: Enrolling; Phase 4

Conditions: Effect of Drug

Treatments: Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT06333145

EDRA

Details and patient eligibility

About

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

Full 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.

Enrollment: 165 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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165 participants in 3 patient groups

normal group

Experimental group

Description:

BMI: ≥18.5 and \<24

Treatment:

Drug: Remimazolam

overweight group

Experimental group

Description:

BMI: ≥24 and \<30

Treatment:

Drug: Remimazolam

obese group

Experimental group

Description:

BMI: ≥30

Treatment:

Drug: Remimazolam