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
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 Names:
  • 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 Names:
  • 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.

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.

Sponsor

Nanjing First Hospital, Nanjing Medical University

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

Helpful Links

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

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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