Combination of Remimazolam and Propofol During Drug-induced Sleep Endoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-08-01

Brief Summary

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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Application of remimazolam and propofol to achieve satisfactory sedative effect

Group Type EXPERIMENTAL

Remimazolam and Propofol

Intervention Type DRUG

Application of Remimazolam and Propofol to induce sleep

Application of propofol to achieve satisfactory sedative effect

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Application of Propofol to induce sleep

Application of midazolam and propofol to achieve satisfactory sedative effect

Group Type ACTIVE_COMPARATOR

Midazolam and propofol

Intervention Type DRUG

Application of Midazolam and Propofol to induce sleep

Interventions

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Remimazolam and Propofol

Application of Remimazolam and Propofol to induce sleep

Intervention Type DRUG

Propofol

Application of Propofol to induce sleep

Intervention Type DRUG

Midazolam and propofol

Application of Midazolam and Propofol to induce sleep

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No