BIS of Sedation Depth During Flexible Bronchoscopy.

Not Applicable

• Conditions: Pulmonary Disease
• Interventions: Drug: Fentanyl; Drug: Midazolam; Drug: Propofol; Device: Bispectral Index monitoring

• Registration Number: NCT03395093
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-07-21
• Study First Submitted: 2017-12-25
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-08
• Last Update Submitted: 2018-01-08
• Study First Posted: 2018-01-10
• Last Update Posted: 2018-01-10
• Primary Completion: 2018-06-30
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FB with fentanyl	Fentanyl	In the Bispectral Index monitoring,our study will use midazolam, propofol and fentanyl in the conscious sedation of FB
FB with fentanyl	Midazolam	In the Bispectral Index monitoring,our study will use midazolam, propofol and fentanyl in the conscious sedation of FB
FB with fentanyl	Propofol	In the Bispectral Index monitoring,our study will use midazolam, propofol and fentanyl in the conscious sedation of FB
FB with fentanyl	Bispectral Index monitoring	In the Bispectral Index monitoring,our study will use midazolam, propofol and fentanyl in the conscious sedation of FB
FB without fentanyl	Bispectral Index monitoring	In the Bispectral Index monitoring, our study will use midazolam, propofol in the conscious sedation of FB
FB without fentanyl	Propofol	In the Bispectral Index monitoring, our study will use midazolam, propofol in the conscious sedation of FB
FB without fentanyl	Midazolam	In the Bispectral Index monitoring, our study will use midazolam, propofol in the conscious sedation of FB

Primary Outcome Measures

Name	Time	Method
perioperative changes of blood pressure	every 5 minutes from the operation beginning to end	For each patient,bispectral index monitoring after anesthesia. Bp will be measured.

Secondary Outcome Measures

Name	Time	Method
perioperative time	from the operation beginning to end	For each patient, record the time bronchoscopy in and out
Adverse events	in the process of the operation	For each patient, Adverse events (overall intraoperative cough,bleeding,low oxygen solution) will be record in the operation
Patient satisfaction rate	One day after the operation	One day after the patient do the bronchoscopy, ask him/her about the satisfaction to the operation