The Effect and Safety of Different Sedation Strategies for Diagnostic Bronchoscopy
Overview
- Phase
- Not Applicable
- Intervention
- Midazolam
- Conditions
- Bronchoscopy
- Sponsor
- Changhai Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Cough score
- Last Updated
- 6 years ago
Overview
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.
Investigators
Jia-feng Wang
Clinical Professor
Changhai Hospital
Eligibility Criteria
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
Arms & Interventions
F
Sedated with intravenous midazolam (0.03mg/kg) and fentanyl (1μg/kg) for induction and maintenance
Intervention: Midazolam
F
Sedated with intravenous midazolam (0.03mg/kg) and fentanyl (1μg/kg) for induction and maintenance
Intervention: Fentanyl
DR
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
Intervention: Midazolam
DR
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
Intervention: Dexmedetomidine
DR
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
Intervention: Remifentanil
DF
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
Intervention: Midazolam
DF
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
Intervention: Fentanyl
DF
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
Intervention: Dexmedetomidine
PR
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
Intervention: Midazolam
PR
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
Intervention: Remifentanil
PR
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
Intervention: Propofol
Outcomes
Primary Outcomes
Cough score
Time Frame: 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 Outcomes
- Amount of the rescue use of propofol(After sedation induction, assessed up to 2 hours)
- Recovery time(After termination of the sedation medication, assessed up to 2 hours)
- Prevalence of the side effects of respiratory and circulatory system(Across the sedation duration, assessed up to 2 hours)
- Body movement(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(Across the procedure, assessed up to 2 hours)