BIS of Sedation Depth During Flexible Bronchoscopy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-21

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bispectral Index-guided Sedation for Flexible Bronchoscopy

NCT00789815

Flexible Bronchoscopy

COMPLETED PHASE4

Narcotrend Versus Bispectral Index Monitoring During Sufentanil-Midazolam Anesthesia for Bronchoscopy

NCT03738137

Bronchoscopy

COMPLETED NA

Automated Anesthesia During Bronchoscopy

NCT00571181

Anesthesia, General

COMPLETED PHASE4

Comparison of Sufentanil, Fentanyl and Remifentanil in Combination With Midazolam During Bronchoscopy Under Conscious Sedation

NCT03901716

Sufentanil Remifentanil Fentanyl +3 more

COMPLETED PHASE4

Bronchoscopy and Bispectral Index (BIS) - Guided Sedation

NCT00839371

Bronchoscopy

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FB with fentanyl

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

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

Five minutes before the patients is done the flexible bronchoscopy, fentanyl will be intravenous injected.

Midazolam

Intervention Type DRUG

Five minutes before the patients is done the flexible bronchoscopy, midazolam will be intravenous injected.

Propofol

Intervention Type DRUG

Propofol will be intravenous injected as soon as the flexible bronchoscopy begins.

Bispectral Index monitoring

Intervention Type DEVICE

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

FB without fentanyl

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

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Five minutes before the patients is done the flexible bronchoscopy, midazolam will be intravenous injected.

Propofol

Intervention Type DRUG

Propofol will be intravenous injected as soon as the flexible bronchoscopy begins.

Bispectral Index monitoring

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fentanyl

Five minutes before the patients is done the flexible bronchoscopy, fentanyl will be intravenous injected.

Intervention Type DRUG

Midazolam

Five minutes before the patients is done the flexible bronchoscopy, midazolam will be intravenous injected.

Intervention Type DRUG

Propofol

Propofol will be intravenous injected as soon as the flexible bronchoscopy begins.

Intervention Type DRUG

Bispectral Index monitoring

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

fentanest fantail sublimaze Ro-21-3981 diprivan disoprofol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No