Sedation Strategies for Therapeutic Bronchoscopy 2

Sedation Clinical Trial

Official title:

Comparison of Sedation and General Anesthesia With Laryngeal Mask in Therapeutic Bronchoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03983915
• Other study ID #: SED-TFB2
• 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

Therapeutic bronchoscopy is a common procedure to treat respiratory diseases. The procedure includes stent implantation, bronchus dilation, electronic incision, laser therapy, and so on. Most of these procedures are painful and require general anesthesia. Conventionally, the general anesthesia for therapeutic bronchoscopy was performed using laryngeal mask. But in the previous experiences, the investigators found that sedation with dexmedetomidine and remifentanil was as effect as laryngeal mask anesthesia. The present study was performed to compare the two approach for sedation or anesthesia in therapeutic bronchoscopy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• 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 therapeutic 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:
• Dexmedetomidine
Dexmedetomidine was used as a sedation agent with less side effect on respiratory system.
• Remifentanil
Remifentanil was used to prevent cough induced by bronchoscopy.

Device:
• Laryngeal mask
Laryngeal mask was used to ensure respiration function during general anesthesia.

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	Recovery time	Duration of the recovery from sedation	After termination of the sedation medication, assessed up to 3 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 3 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 or anesthesia, assessed up to 3 hours
Secondary	Cost of anesthesia or sedation		Across the sedation or anesthesia, assessed up to 3 hours
Secondary	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 3 hours
Secondary	The numbers of the times of 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 3 hours