The Effect and Safety of Different Sedation Strategies for Diagnostic Bronchoscopy

Sedation Strategies for Diagnostic Bronchoscopy 2

Sponsors

Lead sponsor: Changhai Hospital

Collaborator: Shanghai Zhongshan Hospital
Ruijin Hospital
Shanghai Pulmonary Hospital, Shanghai, China

Source 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.

Overall Status Not yet recruiting
Start Date June 17, 2019
Completion Date December 31, 2019
Primary Completion Date November 30, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Cough score From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours
Secondary Outcome
Measure Time Frame
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
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
Enrollment 200
Condition
Intervention

Intervention type: Drug

Intervention name: Midazolam

Description: Midazolam is used as a common medication for sedation in all groups.

Intervention type: Drug

Intervention name: Fentanyl

Description: Fentanyl is another opioid drug used for analgesia to prevent bronchoscopy induced cough.

Intervention type: Drug

Intervention name: Dexmedetomidine

Description: Dexmedetomidine is used for sedation in bronchoscopy with less impact on respiration.

Intervention type: Drug

Intervention name: Remifentanil

Description: Remifentanil is used for analgesia to prevent bronchoscopy induced cough.

Intervention type: Drug

Intervention name: Propofol

Description: Propofol is used for sedation with high efficacy but more side effect on respiration than dexmedetomidine.

Arm group label: PR

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

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Contact

Last name: Jia-feng Wang, MD

Phone: +862131161869

Email: [email protected]

Location
facility Faculty of Anesthesiology, Changhai Hospital
Location Countries

China

Verification Date

June 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Changhai Hospital

Investigator full name: Jia-feng Wang

Investigator title: Clinical Professor

Has Expanded Access No
Number Of Arms 4
Arm Group

Arm group label: F

Arm group type: Experimental

Description: Sedated with intravenous midazolam (0.03mg/kg) and fentanyl (1μg/kg) for induction and maintenance

Arm group label: DR

Arm group type: Experimental

Description: 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

Arm group label: DF

Arm group type: Experimental

Description: 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

Arm group label: PR

Arm group type: Experimental

Description: 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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov