Pulmonary DiseaseBISNCT03395093
BIS of Sedation Depth During Flexible Bronchoscopy.
A study testing Fentanyl, Midazolam and Propofol in people with Pulmonary Disease, run by Nanjing First Hospital, Nanjing Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- Fentanyl, Midazolam and Propofol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 21 Jul 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cough reflex is good agree to do bronchoscopy agree to take part in the study no the contraindication of bronchoscopy
Who cannot join
- 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)
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Disease
- Keywords
- bronchoscopy, conscious sedation, fentanyl, Bispectral Index
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called fentanest, fantail, sublimaze
Five minutes before the patients is done the flexible bronchoscopy, fentanyl will be intravenous injected.
MidazolamDrug
Also called Ro-21-3981
Five minutes before the patients is done the flexible bronchoscopy, midazolam will be intravenous injected.
PropofolDrug
Also called diprivan, disoprofol
Propofol will be intravenous injected as soon as the flexible bronchoscopy begins.
Bispectral Index monitoringDevice
Bispectral Index monitoring will be used in the process of the flexible bronchoscopy.
| Study group | Role | What they receive |
|---|---|---|
| FB with fentanyl | Experimental | In the Bispectral Index monitoring,our study will use midazolam, propofol and fentanyl in the conscious sedation of FB Receives: Drug: Fentanyl; Drug: Midazolam; Drug: Propofol; Device: Bispectral Index monitoring |
| FB without fentanyl | Active comparator | In the Bispectral Index monitoring, our study will use midazolam, propofol in the conscious sedation of FB Receives: Drug: Midazolam; Drug: Propofol; Device: Bispectral Index monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
perioperative changes of blood pressure
For each patient,bispectral index monitoring after anesthesia. Bp will be measured.
Measured: every 5 minutes from the operation beginning to end
Secondary outcomes (3)
perioperative time
For each patient, record the time bronchoscopy in and out
Measured: from the operation beginning to end
Adverse events
For each patient, Adverse events (overall intraoperative cough,bleeding,low oxygen solution) will be record in the operation
Measured: in the process of the operation
Patient satisfaction rate
One day after the patient do the bronchoscopy, ask him/her about the satisfaction to the operation
Measured: One day after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start21 Jul 2016
- Primary completion30 Jun 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wei gu, master, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395093
- Sponsor's protocol ID
- YL20160713-021
- Acronym
- BIS
- Status last verified
- Jan 2018
- First submitted
- 25 Dec 2017
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19443532Wahidi 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.
PubMed 22045879
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bispectral Index Monitoring of Sedation Depth During Flexible Bronchoscopy: With or Without Fentanyl .
- ClinicalTrials.gov ID
- NCT03395093
- Acronym / sponsor ID
- BIS / YL20160713-021
- Conditions
- Pulmonary Disease
- Keywords
- bronchoscopy, conscious sedation, fentanyl, Bispectral Index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 21 Jul 2016 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FB with fentanyl | Experimental | Drug: Fentanyl, Drug: Midazolam, Drug: Propofol, Device: Bispectral Index monitoringIn the Bispectral Index monitoring,our study will use midazolam, propofol and fentanyl in the conscious sedation of FB |
| FB without fentanyl | Active comparator | Drug: Midazolam, Drug: Propofol, Device: Bispectral Index monitoringIn the Bispectral Index monitoring, our study will use midazolam, propofol in the conscious sedation of FB |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cough reflex is good agree to do bronchoscopy agree to take part in the study no the contraindication of bronchoscopy
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylAlso: fentanest, fantail, sublimazeFive minutes before the patients is done the flexible bronchoscopy, fentanyl will be intravenous injected. | Drug | FB with fentanyl |
| MidazolamAlso: Ro-21-3981Five minutes before the patients is done the flexible bronchoscopy, midazolam will be intravenous injected. | Drug | FB with fentanyl, FB without fentanyl |
| PropofolAlso: diprivan, disoprofolPropofol will be intravenous injected as soon as the flexible bronchoscopy begins. | Drug | FB with fentanyl, FB without fentanyl |
| Bispectral Index monitoringBispectral Index monitoring will be used in the process of the flexible bronchoscopy. | Device | FB with fentanyl, FB without fentanyl |
Primary outcome
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.
3 secondary outcomes
perioperative time
Time frame: from the operation beginning to end
Adverse events
Time frame: in the process of the operation
Patient satisfaction rate
Time frame: One day after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Results publication: PubMed 19443532Clark 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 publication: PubMed 22045879Wahidi 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.
- Titrated sedation with propofol or midazolam for flexible bronchoscopy: a randomised trial.Link provided by the sponsor.
- American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wei gu, master principal investigator
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl, Midazolam and Propofol in people with Pulmonary Disease, run by Nanjing First Hospital, Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perioperative changes of blood pressure (time frame: every 5 minutes from the operation beginning to end). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03395093, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018; AzTrials last refreshed its copy on 6 Nov 2026.