Sedation Strategies for Therapeutic Bronchoscopy 2

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Sedation and General Anesthesia With Laryngeal Mask in Therapeutic Bronchoscopy

Conditions
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Bronchoscopy, Sedation

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Remifentanil
* Device: Laryngeal mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for flexible therapeutic bronchoscopy Adult patients aged 18 to 65 years American Society of Anesthesiologists (ASA) Physical Status Classification I-II BMI 18.5-25kg/m2 Subjects provide informed consent Exclusion Criteria: Severe airway obstruction Coagulation disorder Repeat bronchoscopy (more than 3 times) Severe liver and renal dysfunction Cardiovascular and cerebrovascular diseases Pregnancy Chronic opioid user Drug abusers or addicts

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group DR<br>Patients sedated with dexmedetomidine and remifentanil. | Drug: Dexmedetomidine<br>* Dexmedetomidine was used as a sedation agent with less side effect on respiratory system.<br>Drug: Remifentanil<br>* Remifentanil was used to prevent cough induced by bronchoscopy.<br>|
| Experimental: Group LMA<br>General anesthesia was applied using laryngeal mask. | Device: Laryngeal mask<br>* Laryngeal mask was used to ensure respiration function during general anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery time | Duration of the recovery from sedation | After termination of the sedation medication, assessed up to 3 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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, tachycardia, 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 |