Combination of Remimazolam and Propofol During Drug-induced Sleep Endoscopy

Phase 4Active Not RecruitingNCT06784479

Dan Liu174 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

174

Conditions

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

Interventions

Remimazolam and PropofolDRUG

Application of Remimazolam and Propofol to induce sleep

PropofolDRUG

Application of Propofol to induce sleep

Midazolam and propofolDRUG

Application of Midazolam and Propofol to induce sleep

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Respiratory Endoscopy Center of Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Outcomes

Primary Outcomes

sedation success rate

a composite measure including completion of the DISE, no requirement for rescue sedative medication, and no requirement for more than 5 top-up doses of the trial medication after the initial dose.