Sedation Strategies for Therapeutic Bronchoscopy 2

Not Applicable

• Conditions: Bronchoscopy; Sedation
• Interventions: Device: Laryngeal mask; Drug: Dexmedetomidine; Drug: Remifentanil

• Registration Number: NCT03983915
• Lead Sponsor: Changhai Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-10
• Study First Posted: 2019-06-12
• Last Update Submitted: 2019-06-12
• Last Update Posted: 2019-06-14
• Study Start: 2019-06-17
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group LMA	Laryngeal mask	General anesthesia was applied using laryngeal mask.
Group DR	Dexmedetomidine	Patients sedated with dexmedetomidine and remifentanil.
Group DR	Remifentanil	Patients sedated with dexmedetomidine and remifentanil.

Primary Outcome Measures

Name	Time	Method
Recovery time	After termination of the sedation medication, assessed up to 3 hours	Duration of the recovery from sedation

Secondary Outcome Measures

Name	Time	Method
Prevalence of the side effects of respiratory and circulatory system	Across the sedation or anesthesia, assessed up to 3 hours	The number of the side effects in respiratory and circulatory system during the procedure, including hypertension, hypotension, tachycardia, bradycardia, hypoxia and larynx spasm.
Satisfaction score of the patients and bronchoscopists	Across the procedure, assessed up to 3 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.
The numbers of the times of body movement	From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 hours	The numbers of the times of any body movement across the procedure
Cost of anesthesia or sedation	Across the sedation or anesthesia, assessed up to 3 hours
Cough score	From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 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

Trial Locations

Locations (1)

Faculty of Anesthesiology, Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China