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| ID | Type | Description | Link |
|---|---|---|---|
| 82300120 | Other Grant/Funding Number | National Natural Science Foundation of China |
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This study helps patients find the optimal sedation regimen in drug-induced sleep endoscopy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Application of remimazolam and propofol to achieve satisfactory sedative effect | Experimental |
| |
| Application of propofol to achieve satisfactory sedative effect | Active Comparator |
| |
| Application of midazolam and propofol to achieve satisfactory sedative effect | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam and Propofol | Drug | Application of Remimazolam and Propofol to induce sleep |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient) |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure-related adverse effect-The need for antidote administration | Percentage of patients need for antidote administration | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory Endoscopy Center of Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | Application of Propofol to induce sleep |
|
| Midazolam and propofol | Drug | Application of Midazolam and Propofol to induce sleep |
|
Percentage of patients affected tachycardia（ECG monitor） |
| During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient) |
| Procedure-related adverse effect-The occurrence of hypotension | Percentage of patients affected hypotension（ECG monitor） | During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient) |
| Procedure-related adverse effect-The occurrence of hypoxemia | Percentage of patients affected hypoxemia（ECG monitor） | During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient) |
| The degree of patient and physician satisfaction | The percentage of patient and physician satisfacted with the procedure | During procedure (the start of drug induced sleep endoscopy to the complete awakening of the patient) |
| Sedative effect-Adequate sedation time | The doctor evaluate the time it takes for the patient to reach a state of sufficient | During procedure (From the start of medication to target BIS range), an average of 2min |
| Sedative effect-sedation to recovery time | The process of a patient recovering from anesthesia to complete wakefulness | The time period of the end of operation to complete wakefulness,through operation completion, an average of 30min |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |