BIS of Sedation Depth During Flexible Bronchoscopy.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pulmonary Disease

Intervention / Treatment
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* Drug: Fentanyl
* Drug: Midazolam
* Drug: Propofol
* Device: Bispectral Index monitoring


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FB with fentanyl<br>In the Bispectral Index monitoring,our study will use midazolam, propofol and fentanyl in the conscious sedation of FB | Drug: Fentanyl<br>* Five minutes before the patients is done the flexible bronchoscopy, fentanyl will be intravenous injected.<br>* Other names: sublimaze;Drug: Midazolam<br>* Five minutes before the patients is done the flexible bronchoscopy, midazolam will be intravenous injected.<br>* Other names: Ro-21-3981;Drug: Propofol<br>* Propofol will be intravenous injected as soon as the flexible bronchoscopy begins.<br>* Other names: disoprofol;Device: Bispectral Index monitoring<br>* Bispectral Index monitoring will be used in the process of the flexible bronchoscopy.<br>|
| Active Comparator: FB without fentanyl<br>In the Bispectral Index monitoring, our study will use midazolam, propofol in the conscious sedation of FB | Drug: Midazolam<br>* Five minutes before the patients is done the flexible bronchoscopy, midazolam will be intravenous injected.<br>* Other names: Ro-21-3981;Drug: Propofol<br>* Propofol will be intravenous injected as soon as the flexible bronchoscopy begins.<br>* Other names: disoprofol;Device: Bispectral Index monitoring<br>* Bispectral Index monitoring will be used in the process of the flexible bronchoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative time | For each patient, record the time bronchoscopy in and out | from the operation beginning to end | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bronchoscopy, conscious sedation, fentanyl, Bispectral Index