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BIS of Sedation Depth During Flexible Bronchoscopy. (BIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395093
Recruitment Status : Unknown
Verified January 2018 by Nanjing First Hospital, Nanjing Medical University.
Recruitment status was:  Active, not recruiting
First Posted : January 10, 2018
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Nanjing First Hospital, Nanjing Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease Drug: Fentanyl Drug: Midazolam Drug: Propofol Device: Bispectral Index monitoring Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bispectral Index Monitoring of Sedation Depth During Flexible Bronchoscopy: With or Without Fentanyl .
Actual Study Start Date : July 21, 2016
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: FB with fentanyl
In the Bispectral Index monitoring,our study will use midazolam, propofol and fentanyl in the conscious sedation of FB
 Drug: Fentanyl
Five minutes before the patients is done the flexible bronchoscopy, fentanyl will be intravenous injected.
Other Names:
  • fentanest
  • fantail
  • sublimaze

Drug: Midazolam
Five minutes before the patients is done the flexible bronchoscopy, midazolam will be intravenous injected.
Other Name: Ro-21-3981

Drug: Propofol
Propofol will be intravenous injected as soon as the flexible bronchoscopy begins.
Other Names:
  • diprivan
  • disoprofol

Device: Bispectral Index monitoring
Bispectral Index monitoring will be used in the process of the flexible bronchoscopy.
Active Comparator: FB without fentanyl
In the Bispectral Index monitoring, our study will use midazolam, propofol in the conscious sedation of FB
 Drug: Midazolam
Five minutes before the patients is done the flexible bronchoscopy, midazolam will be intravenous injected.
Other Name: Ro-21-3981

Drug: Propofol
Propofol will be intravenous injected as soon as the flexible bronchoscopy begins.
Other Names:
  • diprivan
  • disoprofol

Device: Bispectral Index monitoring
Bispectral Index monitoring will be used in the process of the flexible bronchoscopy.


Outcome Measures
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Primary Outcome Measures :
  1. perioperative changes of blood pressure [ Time Frame: every 5 minutes from the operation beginning to end ]
    For each patient,bispectral index monitoring after anesthesia. Bp will be measured.


Secondary Outcome Measures :
  1. perioperative time [ Time Frame: from the operation beginning to end ]
    For each patient, record the time bronchoscopy in and out

  2. Adverse events [ Time Frame: in the process of the operation ]
    For each patient, Adverse events (overall intraoperative cough,bleeding,low oxygen solution) will be record in the operation

  3. Patient satisfaction rate [ Time Frame: One day after the operation ]
    One day after the patient do the bronchoscopy, ask him/her about the satisfaction to the operation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395093


Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Investigators
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Principal Investigator: wei gu, master The First Affiliated Hospital with Nanjing Medical University
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03395093    
Other Study ID Numbers: YL20160713-021
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Nanjing First Hospital, Nanjing Medical University:
bronchoscopy
conscious sedation
fentanyl
Bispectral Index
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Fentanyl
Midazolam
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
 Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action