Sedative Effect During Drug-induced Sleep Endoscopy, Obstructive Sleep Apnea (OSA)
Conditions
Keywords
drug-induced sleep endoscopy, remimazolam, propofol, Obstructive sleep apnea, airway collapsibility
Brief summary
This study helps patients find the optimal sedation regimen in drug-induced sleep endoscopy
Interventions
DRUGRemimazolam and Propofol
Application of Remimazolam and Propofol to induce sleep
DRUGPropofol
Application of Propofol to induce sleep
Application of Midazolam and Propofol to induce sleep
Sponsors
Dan Liu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sedation success rate | During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Sedative effect-Adequate sedation time | During procedure (From the start of medication to target BIS range), an average of 2min | The doctor evaluate the time it takes for the patient to reach a state of sufficient |
| 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 |
Countries
China
Outcome results
None listed