Combination of Remimazolam and Propofol During Drug-induced Sleep Endoscopy

Dan Liu

Status and phase: Invitation-only; Phase 4

Conditions: Obstructive Sleep Apnea (OSA); Sedative Effect During Drug-induced Sleep Endoscopy

Treatments: Drug: Midazolam and propofol; Drug: Propofol; Drug: Remimazolam and Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06784479

IRB2024-YX-607-01

82300120 (Other Grant/Funding Number)

Details and patient eligibility

About

This study helps patients find the optimal sedation regimen in drug-induced sleep endoscopy

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with sleep apnea hypopnea syndrome were included

Exclusion criteria

• Patients were excluded if they had nasal obstruction, significantly deviated nasal septum, nasal turbinate hypertrophy, or nasal polyps. Patients with uncontrolled heart failure, renal insufficiency, diabetes, or hyperthyroidism were also excluded. Patients were also excluded if taking medications that could affect upper airway muscle function, such as ben- zodiazepines and muscle relaxants.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 3 patient groups

Application of remimazolam and propofol to achieve satisfactory sedative effect

Experimental group

Treatment:

Drug: Remimazolam and Propofol

Application of propofol to achieve satisfactory sedative effect

Active Comparator group

Treatment:

Drug: Propofol

Application of midazolam and propofol to achieve satisfactory sedative effect

Active Comparator group

Treatment:

Drug: Midazolam and propofol