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Appropriate sedation is needed for medical diagnosis, treatment, and the safety for patients. In non-surgical approaches, benzodiazepines are broadly used for ideal sedated status for patients.
It is necessary to compare the efficacy and safety of dexmedetomidine with that of midazolam in ultrasound guided transbronchial needle aspiration (EBUS-TBNA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| midazolam | Active Comparator | midazolam IV bolus 0.05ml/kg bolus in 1minute. rescue drug(Midazolam) 1 mg, IV boluses for double blinding setting, we use saline, 0.4 mcg/kg IV bolus in 10 minutes and 0.5 mcg/kg/h, as placebo. |
|
| Dexmedetomidine | Experimental | Dexmedetomidine 0.4 mcg/kg IV bolus in 10 minutes. Dexmedetomidine 0.25-0.75 mcg/kg/h for RSS 3-5. Midazolam 1mg bolus IV pro re nata (PRN). for double blinding setting, IV bolus 0.05ml/kg bolus in 1minute. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| midazolam | Drug |
| ||
| Dexmedetomidine |
| Measure | Description | Time Frame |
|---|---|---|
| The number of Desaturation events | The number of desaturation (SpO2 <90% for more than 5 seconds) events | Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| RSS score | RSS score: at the beginning of the procedure, minimum RSS score, every 5 minute | Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours |
| Total dose of intratracheal lidocaine instillation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-799 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33122573 | Derived | Kim J, Choi SM, Park YS, Lee CH, Lee SM, Yoo CG, Kim YW, Lee J. Dexmedetomidine versus midazolam for sedation during endobronchial ultrasound-guided transbronchial needle aspiration: A randomised controlled trial. Eur J Anaesthesiol. 2021 May 1;38(5):534-540. doi: 10.1097/EJA.0000000000001370. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 18, 2021 | |
| Reset | Sep 14, 2021 | |
| Release | Sep 16, 2021 | |
| Reset | Oct 13, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 18, 2021 | Sep 14, 2021 | |||
| Sep 16, 2021 |
| ID | Term |
|---|---|
| D008874 | Midazolam |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Cumulative dose of lidocaine administered at bronchus by the endoscopist for local anesthesia by topical instillation. Topical lidocaine instillation is performed in both the two arms for procedure as routine bronchoscopy. |
| Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours |
| Endoscopist satisfaction | Endoscopist global satisfaction score based on a VAS score | Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room |
| Patient satisfaction | Global patient satisfaction associated with the procedure. Score based on a VAS score measured before the patients leave the bronchoscopy room. | Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours |
| Use of rescue midazolam | Use of rescue midazolam, total dose | Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours |
| Duration of desaturation (sec) | Patient followed for the entire duration of EBUS-TBNA, an expected average of 2 hours |
| Hemodynamic adverse event | Hypotension ( < mean BP 60 mmHg) Bradycardia ( < 50 bpm) | Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours |
| Oct 13, 2021 |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |