BIS of Sedation Depth During Flexible Bronchoscopy.

Pulmonary Disease Clinical Trial

— BIS  

Official title:

Bispectral Index Monitoring of Sedation Depth During Flexible Bronchoscopy: With or Without Fentanyl .

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03395093
• Other study ID #: YL20160713-021
• Status: Active, not recruiting
• Phase: N/A
• First received: December 25, 2017
• Last updated: January 8, 2018
• Start date: July 21, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2018
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fentanyl is analgesia medication. There has not pain nerve in the lung. Flexible bronchoscopy(FB) is used in the respiratory medicine. So people will not feel pain in the process of FB. The purpose of the study is to know if Fentanyl is useful in the conscious sedation of FB.

Description:

Fentanyl is opioid receptor agonists. It is a fast-acting, short duration and potent analgesics.

Flexible bronchoscopy (FB) is mostly used in the diagnosis and therapy in the respiratory disease. As we know, there has not pain nerve in the lung. People will not feel pain when they are in FB.

If fentanyl will be effective in FB? Our study will observe the effect of conscious sedation in FB with fentanyl or without fentanyl.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Cough reflex is good agree to do bronchoscopy agree to take part in the study no the contraindication of bronchoscopy

Exclusion Criteria:

Forced expiratory volume in one second<1 L severe hemoptysis severe heart, liver,kidney failure psychiatric and nervous disorders allergic to the anesthetic ( fentanyl, midazolam, or propofol)

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease

Intervention

Drug:
• Fentanyl
Five minutes before the patients is done the flexible bronchoscopy, fentanyl will be intravenous injected.
• Midazolam
Five minutes before the patients is done the flexible bronchoscopy, midazolam will be intravenous injected.
• Propofol
Propofol will be intravenous injected as soon as the flexible bronchoscopy begins.

Device:
• Bispectral Index monitoring
Bispectral Index monitoring will be used in the process of the flexible bronchoscopy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

References & Publications (2)

Clark G, Licker M, Younossian AB, Soccal PM, Frey JG, Rochat T, Diaper J, Bridevaux PO, Tschopp JM. Titrated sedation with propofol or midazolam for flexible bronchoscopy: a randomised trial. Eur Respir J. 2009 Dec;34(6):1277-83. doi: 10.1183/09031936.001 — View Citation

Wahidi MM, Jain P, Jantz M, Lee P, Mackensen GB, Barbour SY, Lamb C, Silvestri GA. American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients. Chest. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perioperative changes of blood pressure	For each patient,bispectral index monitoring after anesthesia. Bp will be measured.	every 5 minutes from the operation beginning to end
Secondary	perioperative time	For each patient, record the time bronchoscopy in and out	from the operation beginning to end
Secondary	Adverse events	For each patient, Adverse events (overall intraoperative cough,bleeding,low oxygen solution) will be record in the operation	in the process of the operation
Secondary	Patient satisfaction rate	One day after the patient do the bronchoscopy, ask him/her about the satisfaction to the operation	One day after the operation

External Links

•   American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients.
•   Titrated sedation with propofol or midazolam for flexible bronchoscopy: a randomised trial.