Pulmonary Disease Clinical Trial
— BISOfficial title:
Bispectral Index Monitoring of Sedation Depth During Flexible Bronchoscopy: With or Without Fentanyl .
Verified date | January 2018 |
Source | Nanjing First Hospital, Nanjing Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Nanjing First Hospital, Nanjing Medical University |
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
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 |
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