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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03406533
Other study ID # SED-DFB
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date March 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

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 Terminated
Enrollment 28
Est. completion date March 31, 2018
Est. primary completion date March 30, 2018
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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Midazolam
Midazolam is used as a common medication for sedation in all groups.
Dexmedetomidine
Dexmedetomidine is used for sedation in bronchoscopy with less impact on respiration.
Remifentanil
Remifentanil is used for analgesia to prevent bronchoscopy induced cough.
Fentanyl
Fentanyl is another opioid drug 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. 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, tackycardia, bradycardia, hypoxia and larynx spasm. Across the sedation duration, assessed up to 2 hours
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