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

Sedative effect-Adequate sedation time

The doctor evaluate the time it takes for the patient to reach a state of sufficient sedation

Time frame: During procedure (From the start of medication to adequate sedation time), an average of 5min

Sedative effect-operation time

Adequate sedation time, hemodynamic response, operation time, sedation to recovery time, wake-up time

Time frame: From the start of drug induced sleep endoscopy to the complete the operation, an average of 10min

Sedative effect-sedation to recovery time

The process of a patient recovering from anesthesia to complete wakefulness

Time frame: The time period of the end of operation to complete wakefulness,through operation completion, an average of 30min

Sedative effect-sedation to wake-up time

The process of the patient wakes up from anesthesia

Time frame: During procedure (The time period of the doctor's call to the patient's awakening from anesthesia), an average of 10min

Secondary Outcomes

Procedure-related adverse effect-The need for antidote administration

Percentage of patients need for antidote administration

Time frame: During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)

Procedure-related adverse effect-The occurrence of tachycardia

Percentage of patients affected tachycardia（ECG monitor）

Time frame: During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)

Data from ClinicalTrials.gov

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