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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03406546
Other study ID # SED-TFB
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date July 31, 2018

Study information

Verified date June 2019
Source Changhai Hospital
Contact n/a
Is FDA regulated No
Health authority
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 Terminated
Enrollment 20
Est. completion date July 31, 2018
Est. primary completion date June 30, 2018
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

Study Design


Related Conditions & MeSH terms


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, tackycardia, 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
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