Clinical trial NCT06784479: Combination of Remimazolam and Propofol During Drug-induced Sleep Endoscopy
Official title: A Randomized Clinical Trial to Evaluate the Sedative Effect of the Combination of Remimazolam and Propofol in Drug-induced Sleep Endoscopy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Sedative Effect During Drug-induced Sleep Endoscopy
Obstructive Sleep Apnea (OSA)
Keywords: drug-induced sleep endoscopy
remimazolam
propofol
Obstructive sleep apnea
airway collapsibility
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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.

Primary outcomes:
measure: Sedative effect-Adequate sedation time
timeFrame: During procedure (From the start of medication to adequate sedation time), an average of 5min
measure: Sedative effect-operation time
timeFrame: From the start of drug induced sleep endoscopy to the complete the operation, an average of 10min
measure: Sedative effect-sedation to recovery time
timeFrame: The time period of the end of operation to complete wakefulness,through operation completion, an average of 30min
measure: Sedative effect-sedation to wake-up time
timeFrame: During procedure (The time period of the doctor's call to the patient's awakening from anesthesia), an average of 10min
Secondary outcomes:
measure: Procedure-related adverse effect-The need for antidote administration
timeFrame: During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)
measure: Procedure-related adverse effect-The occurrence of tachycardia
timeFrame: During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)
measure: Procedure-related adverse effect-The occurrence of hypotension
timeFrame: During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)
measure: Procedure-related adverse effect-The occurrence of hypoxemia
timeFrame: During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)
measure: The degree of patient and physician satisfaction
timeFrame: During procedure (the start of drug induced sleep endoscopy to the complete awakening of the patient)
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Respiratory Endoscopy Center of Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References: