Combination of Remimazolam and Propofol During Drug-induced Sleep Endoscopy

Phase 4

• Conditions: Sedative Effect During Drug-induced Sleep Endoscopy; Obstructive Sleep Apnea (OSA)
• Interventions: Drug: Remimazolam and Propofol; Drug: Propofol; Drug: Midazolam and propofol

• Registration Number: NCT06784479
• Lead Sponsor: Dan Liu

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-31
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20
• Study Start: 2025-02-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Application of remimazolam and propofol to achieve satisfactory sedative effect	Remimazolam and Propofol	-
Application of propofol to achieve satisfactory sedative effect	Propofol	-
Application of midazolam and propofol to achieve satisfactory sedative effect	Midazolam and propofol	-

Primary Outcome Measures

Name	Time	Method
Sedative effect-Adequate sedation time	During procedure (From the start of medication to adequate sedation time), an average of 5min	The doctor evaluate the time it takes for the patient to reach a state of sufficient sedation
Sedative effect-operation time	From the start of drug induced sleep endoscopy to the complete the operation, an average of 10min	Adequate sedation time, hemodynamic response, operation time, sedation to recovery time, wake-up time
Sedative effect-sedation to recovery time	The time period of the end of operation to complete wakefulness,through operation completion, an average of 30min	The process of a patient recovering from anesthesia to complete wakefulness
Sedative effect-sedation to wake-up time	During procedure (The time period of the doctor's call to the patient's awakening from anesthesia), an average of 10min	The process of the patient wakes up from anesthesia

Secondary Outcome Measures

Name	Time	Method
Procedure-related adverse effect-The need for antidote administration	During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)	Percentage of patients need for antidote administration
Procedure-related adverse effect-The occurrence of tachycardia	During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)	Percentage of patients affected tachycardia（ECG monitor）
Procedure-related adverse effect-The occurrence of hypotension	During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)	Percentage of patients affected hypotension（ECG monitor）
Procedure-related adverse effect-The occurrence of hypoxemia	During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)	Percentage of patients affected hypoxemia（ECG monitor）
The degree of patient and physician satisfaction	During procedure (the start of drug induced sleep endoscopy to the complete awakening of the patient)	The percentage of patient and physician satisfacted with the procedure

Trial Locations

Locations (1)

Respiratory Endoscopy Center of Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China