BIS of Sedation Depth During Flexible Bronchoscopy. (BIS)
January 8, 2018 updated by: Nanjing First Hospital, Nanjing Medical University
Bispectral Index Monitoring of Sedation Depth During Flexible Bronchoscopy: With or Without Fentanyl .
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
500
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
Five minutes before the patients is done the flexible bronchoscopy, fentanyl will be intravenous injected.
Other Names:
Five minutes before the patients is done the flexible bronchoscopy, midazolam will be intravenous injected.
Other Names:
Propofol will be intravenous injected as soon as the flexible bronchoscopy begins.
Other Names:
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
|
Five minutes before the patients is done the flexible bronchoscopy, midazolam will be intravenous injected.
Other Names:
Propofol will be intravenous injected as soon as the flexible bronchoscopy begins.
Other Names:
Bispectral Index monitoring will be used in the process of the flexible bronchoscopy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
every 5 minutes from the operation beginning to end
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
perioperative time
Time Frame: from the operation beginning to end
|
For each patient, record the time bronchoscopy in and out
|
from the operation beginning to end
|
|
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
|
in the process of the operation
|
|
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
|
One day after the operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wei Gu, master, The First Affiliated Hospital with Nanjing Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 21, 2016
Primary Completion (Anticipated)
June 30, 2018
Study Completion (Anticipated)
December 31, 2018
Study Registration Dates
First Submitted
December 25, 2017
First Submitted That Met QC Criteria
January 8, 2018
First Posted (Actual)
January 10, 2018
Study Record Updates
Last Update Posted (Actual)
January 10, 2018
Last Update Submitted That Met QC Criteria
January 8, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Fentanyl
- Midazolam
- Propofol
Other Study ID Numbers
- YL20160713-021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
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