BIS of Sedation Depth During Flexible Bronchoscopy.

Nanjing Medical University

Status: Unknown

Conditions: Pulmonary Disease

Treatments: Drug: Fentanyl; Drug: Midazolam; Device: Bispectral Index monitoring; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT03395093

YL20160713-021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

FB with fentanyl

Experimental group

Description:

In the Bispectral Index monitoring,our study will use midazolam, propofol and fentanyl in the conscious sedation of FB

Treatment:

Drug: Propofol

Drug: Midazolam

Drug: Fentanyl

Device: Bispectral Index monitoring

FB without fentanyl

Active Comparator group

Description:

In the Bispectral Index monitoring, our study will use midazolam, propofol in the conscious sedation of FB

Treatment:

Drug: Propofol

Drug: Midazolam

Device: Bispectral Index monitoring