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The sample size should be re-calculated based on the first 20 cases.
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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| Ruijin Hospital | OTHER |
| Shanghai Pulmonary Hospital, Shanghai, China | OTHER |
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Therapeutic bronchoscopy is a common procedure to treat respiratory diseases. The procedure includes stent implantation, bronchus dilation, electronic incision, laser therapy, and so on. Most of these procedures are painful and require general anesthesia. Conventionally, the general anesthesia for therapeutic bronchoscopy was performed using laryngeal mask. But in the previous experiences, the investigators found that sedation with dexmedetomidine and remifentanil was as effect as laryngeal mask anesthesia. The present study was performed to compare the two approach for sedation or anesthesia in therapeutic bronchoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group DR | Experimental | Patients sedated with dexmedetomidine and remifentanil. |
|
| Group LMA | Experimental | General anesthesia was applied using laryngeal mask. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine was used as a sedation agent with less side effect on respiratory system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recovery time | Duration of the recovery from sedation | After termination of the sedation medication, assessed up to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction score of the patients and bronchoscopists | Satisfaction score of the patients and bronchoscopists regarding to the sedation quality measured by a 0-100 visual analogue scale (VAS). 100 refers to the highest satisfaction degree while 0 refers to the worst satisfaction degree. | Across the procedure, assessed up to 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Anesthesiology, Changhai Hospital | Shanghai | Shanghai Municipality | 200433 | China |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077208 | Remifentanil |
| D017214 | Laryngeal Masks |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Remifentanil | Drug | Remifentanil was used to prevent cough induced by bronchoscopy. |
|
| Laryngeal mask | Device | Laryngeal mask was used to ensure respiration function during general anesthesia. |
|
| Prevalence of the side effects of respiratory and circulatory system |
The number of the side effects in respiratory and circulatory system during the procedure, including hypertension, hypotension, tackycardia, bradycardia, hypoxia and larynx spasm. |
| Across the sedation or anesthesia, assessed up to 3 hours |
| Cost of anesthesia or sedation | Across the sedation or anesthesia, assessed up to 3 hours |
| Cough score | Cough score across the procedure will be classified into 4 degree (1-4) as follows. 1 = none, 2 = one gag or cough only, 3 = >1 gag or cough, but acceptable conditions, 4 = unacceptable conditions | From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 hours |
| The numbers of the times of body movement | The numbers of the times of any body movement across the procedure | From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 hours |
| D011422 |
| Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |