Sedation Strategies for Diagnostic Bronchoscopy 2

Sedation Clinical Trial

Official title:

The Effect and Safety of Different Sedation Strategies for Diagnostic Bronchoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03983889
• Other study ID #: SED-DFB2
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2019
• Source: Changhai Hospital
• Contact: Jia-feng Wang, MD
• Phone: +862131161869
• Email: jfwang[@]smmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• 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

Related Conditions & MeSH terms

• Bronchoscopy
• Sedation

Intervention

Drug:
• Midazolam
Midazolam is used as a common medication for sedation in all groups.
• Fentanyl
Fentanyl is another opioid drug used for analgesia to prevent bronchoscopy induced cough.
• Dexmedetomidine
Dexmedetomidine is used for sedation in bronchoscopy with less impact on respiration.
• Remifentanil
Remifentanil is used for analgesia to prevent bronchoscopy induced cough.
• Propofol
Propofol is used for sedation with high efficacy but more side effect on respiration than dexmedetomidine.

Locations

Country	Name	City	State
China	Faculty of Anesthesiology, Changhai Hospital	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Changhai Hospital	Ruijin Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

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. The scale score was determined by the subjective determination of the satisfaction on the sedation quality.	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, tachycardia, bradycardia, hypoxia and larynx spasm.	Across the sedation duration, assessed up to 2 hours