Sedation Strategies for Diagnostic Bronchoscopy 2

Study Overview
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Brief Summary
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Diagnostic bronchoscopy is an invasive procedure performed to diagnose respiratory diseases. But pain has been complained by most of the patients receiving such procedures. Sedation or anesthesia was required by both of the patients and bronchoscopists. Unfortunately, no consensus has been made upon the sedation strategies. Multiple sedation approaches have been applied, such as midazolam and fentanyl, remifentanil and propofol, dexmedetomidine and propofol. The present study was designed to compare these protocols in sedation for diagnostic bronchoscopy.

Official Title
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The Effect and Safety of Different Sedation Strategies for Diagnostic Bronchoscopy

Conditions
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Bronchoscopy, Sedation

Intervention / Treatment
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* Drug: Midazolam
* Drug: Fentanyl
* Drug: Dexmedetomidine
* Drug: Remifentanil
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for flexible diagnostic 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F<br>Sedated with intravenous midazolam (0.03mg/kg) and fentanyl (1μg/kg) for induction and maintenance | Drug: Midazolam<br>* Midazolam is used as a common medication for sedation in all groups.<br>Drug: Fentanyl<br>* Fentanyl is another opioid drug used for analgesia to prevent bronchoscopy induced cough.<br>|
| Experimental: DR<br>Sedated with intravenous midazolam (0.03mg/kg), dexmedetomidine (0.5-1μg/kg for induction+0.5-0.7μg/kg/h for maintenance) and remifentanil (plasma concentration 2.0-2.5ng/ml) for induction and maintenance | Drug: Midazolam<br>* Midazolam is used as a common medication for sedation in all groups.<br>Drug: Dexmedetomidine<br>* Dexmedetomidine is used for sedation in bronchoscopy with less impact on respiration.<br>Drug: Remifentanil<br>* Remifentanil is used for analgesia to prevent bronchoscopy induced cough.<br>|
| Experimental: DF<br>Sedated with intravenous midazolam (0.03mg/kg), dexmedetomidine (0.5-1μg/kg for induction+0.5-0.7μg/kg/h for maintenance) and fentanyl (1μg/kg) for induction and maintenance | Drug: Midazolam<br>* Midazolam is used as a common medication for sedation in all groups.<br>Drug: Fentanyl<br>* Fentanyl is another opioid drug used for analgesia to prevent bronchoscopy induced cough.<br>Drug: Dexmedetomidine<br>* Dexmedetomidine is used for sedation in bronchoscopy with less impact on respiration.<br>|
| Experimental: PR<br>Sedated with intravenous midazolam (0.03mg/kg), propofol (plasma concentration 1.0-2.0ng/ml) and remifentanil (plasma concentration 2.0-2.5ng/ml) for induction and maintenance | Drug: Midazolam<br>* Midazolam is used as a common medication for sedation in all groups.<br>Drug: Remifentanil<br>* Remifentanil is used for analgesia to prevent bronchoscopy induced cough.<br>Drug: Propofol<br>* Propofol is used for sedation with high efficacy but more side effect on respiration than dexmedetomidine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 2 hours | 
| 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. The scale score was determined by the subjective determination of the satisfaction on the sedation quality. | Across the procedure, assessed up to 2 hours | 
| Amount of the rescue use of propofol | The total amount of propofol used as a rescue therapy when the sedation is not deep enough as assessed by the anesthesiologists. | After sedation induction, assessed up to 2 hours | 
| Recovery time | Duration of the recovery from sedation | After termination of the sedation medication, assessed up to 2 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 duration, assessed up to 2 hours |