Sedation Clinical Trial
Official title:
The Effect and Safety of Different Sedation Strategies for Diagnostic Bronchoscopy
Verified date | June 2019 |
Source | Changhai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 28 |
Est. completion date | March 31, 2018 |
Est. primary completion date | March 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Faculty of Anesthesiology, Changhai Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital | Ruijin Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Zhongshan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 2 hours | |
Secondary | 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 | |
Secondary | Recovery time | Duration of the recovery from sedation | After termination of the sedation medication, assessed up to 2 hours | |
Secondary | 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 duration, assessed up to 2 hours |
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