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BIS of Sedation Depth During Flexible Bronchoscopy.

Bispectral Index Monitoring of Sedation Depth During Flexible Bronchoscopy: With or Without Fentanyl .

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03395093
Acronym
BIS
Enrollment
500
Registered
2018-01-10
Start date
2016-07-21
Completion date
2018-12-31
Last updated
2018-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease

Keywords

bronchoscopy, conscious sedation, fentanyl, Bispectral Index

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.

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.

Interventions

DRUGFentanyl

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

DRUGMidazolam

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

DRUGPropofol

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

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

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
perioperative changes of blood pressureevery 5 minutes from the operation beginning to endFor each patient,bispectral index monitoring after anesthesia. Bp will be measured.

Secondary

MeasureTime frameDescription
Patient satisfaction rateOne day after the operationOne day after the patient do the bronchoscopy, ask him/her about the satisfaction to the operation
perioperative timefrom the operation beginning to endFor each patient, record the time bronchoscopy in and out
Adverse eventsin the process of the operationFor each patient, Adverse events (overall intraoperative cough,bleeding,low oxygen solution) will be record in the operation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026