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BIS of Sedation Depth During Flexible Bronchoscopy. (BIS)

Primary Purpose

Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fentanyl
Midazolam
Propofol
Bispectral Index monitoring
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease focused on measuring bronchoscopy, conscious sedation, fentanyl, Bispectral Index

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    FB with fentanyl

    FB without fentanyl

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    perioperative changes of blood pressure
    For each patient,bispectral index monitoring after anesthesia. Bp will be measured.

    Secondary Outcome Measures

    perioperative time
    For each patient, record the time bronchoscopy in and out
    Adverse events
    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 patient do the bronchoscopy, ask him/her about the satisfaction to the operation

    Full Information

    First Posted
    December 25, 2017
    Last Updated
    January 8, 2018
    Sponsor
    Nanjing First Hospital, Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03395093
    Brief Title
    BIS of Sedation Depth During Flexible Bronchoscopy.
    Acronym
    BIS
    Official Title
    Bispectral Index Monitoring of Sedation Depth During Flexible Bronchoscopy: With or Without Fentanyl .
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 21, 2016 (Actual)
    Primary Completion Date
    June 30, 2018 (Anticipated)
    Study Completion Date
    December 31, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nanjing First Hospital, Nanjing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Disease
    Keywords
    bronchoscopy, conscious sedation, fentanyl, Bispectral Index

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    500 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FB with fentanyl
    Arm Type
    Experimental
    Arm Description
    In the Bispectral Index monitoring,our study will use midazolam, propofol and fentanyl in the conscious sedation of FB
    Arm Title
    FB without fentanyl
    Arm Type
    Active Comparator
    Arm Description
    In the Bispectral Index monitoring, our study will use midazolam, propofol in the conscious sedation of FB
    Intervention Type
    Drug
    Intervention Name(s)
    Fentanyl
    Other Intervention Name(s)
    fentanest, fantail, sublimaze
    Intervention Description
    Five minutes before the patients is done the flexible bronchoscopy, fentanyl will be intravenous injected.
    Intervention Type
    Drug
    Intervention Name(s)
    Midazolam
    Other Intervention Name(s)
    Ro-21-3981
    Intervention Description
    Five minutes before the patients is done the flexible bronchoscopy, midazolam will be intravenous injected.
    Intervention Type
    Drug
    Intervention Name(s)
    Propofol
    Other Intervention Name(s)
    diprivan, disoprofol
    Intervention Description
    Propofol will be intravenous injected as soon as the flexible bronchoscopy begins.
    Intervention Type
    Device
    Intervention Name(s)
    Bispectral Index monitoring
    Intervention Description
    Bispectral Index monitoring will be used in the process of the flexible bronchoscopy.
    Primary Outcome Measure Information:
    Title
    perioperative changes of blood pressure
    Description
    For each patient,bispectral index monitoring after anesthesia. Bp will be measured.
    Time Frame
    every 5 minutes from the operation beginning to end
    Secondary Outcome Measure Information:
    Title
    perioperative time
    Description
    For each patient, record the time bronchoscopy in and out
    Time Frame
    from the operation beginning to end
    Title
    Adverse events
    Description
    For each patient, Adverse events (overall intraoperative cough,bleeding,low oxygen solution) will be record in the operation
    Time Frame
    in the process of the operation
    Title
    Patient satisfaction rate
    Description
    One day after the patient do the bronchoscopy, ask him/her about the satisfaction to the operation
    Time Frame
    One day after the operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    wei gu, master
    Organizational Affiliation
    The First Affiliated Hospital with Nanjing Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19443532
    Citation
    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: 10.1183/09031936.00142108. Epub 2009 May 14.
    Results Reference
    result
    PubMed Identifier
    22045879
    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. 2011 Nov;140(5):1342-1350. doi: 10.1378/chest.10-3361.
    Results Reference
    result
    Links:
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/19443532
    Description
    Titrated sedation with propofol or midazolam for flexible bronchoscopy: a randomised trial.
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/?term=American+College+of+Chest+Physicians++Consensus+Statement+on+the+Use+of+Topical++Anesthesia%2C+Analgesia%2C+and+Sedation+During+Flexible+Bronchoscopy+in+Adult+Patients
    Description
    American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients.

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