Sedation Strategies for Diagnostic Bronchoscopy
- Conditions
- SedationBronchoscopy
- Interventions
- Registration Number
- NCT03406533
- Lead Sponsor
- Changhai Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group F Midazolam Sedated with midazolam and fentanyl Group DR Remifentanil Sedated with midazolam, dexmedetomidine and remifentanil Group DR Midazolam Sedated with midazolam, dexmedetomidine and remifentanil Group DR Dexmedetomidine Sedated with midazolam, dexmedetomidine and remifentanil Group F Fentanyl Sedated with midazolam and fentanyl Group DF Midazolam Sedated with midazolam, dexmedetomidine and fentanyl Group DF Dexmedetomidine Sedated with midazolam, dexmedetomidine and fentanyl Group DF Fentanyl Sedated with midazolam, dexmedetomidine and fentanyl Group PR Remifentanil Sedated with midazolam, propofol and remifentanil Group PR Midazolam Sedated with midazolam, propofol and remifentanil Group PR Propofol Sedated with midazolam, propofol and remifentanil
- Primary Outcome Measures
Name Time Method Cough score From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours 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
- Secondary Outcome Measures
Name Time Method Body movement From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours The numbers of the times of any body movement across the procedure
Satisfaction score of the patients and bronchoscopists Across the procedure, assessed up to 2 hours 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.
Amount of the rescue use of propofol After sedation induction, assessed up to 2 hours The total amount of propofol used as a rescue therapy when the sedation is not deep enough as assessed by the anesthesiologists.
Recovery time After termination of the sedation medication, assessed up to 2 hours Duration of the recovery from sedation
Prevalence of the side effects of respiratory and circulatory system Across the sedation duration, assessed up to 2 hours The number of the side effects in respiratory and circulatory system during the procedure, including hypertension, hypotension, tackycardia, bradycardia, hypoxia and larynx spasm.
Trial Locations
- Locations (1)
Faculty of Anesthesiology, Changhai Hospital
🇨🇳Shanghai, Shanghai, China