BIS of Sedation Depth During Flexible Bronchoscopy.

NCT03395093 | Unknown

• 1 other identifier: YL20160713-021
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Disease

Keywords

bronchoscopy; conscious sedation; fentanyl; Bispectral Index

Outcome Measures

Primary Outcomes (1)

• perioperative changes of blood pressure

  For each patient,bispectral index monitoring after anesthesia. Bp will be measured.

  every 5 minutes from the operation beginning to end

Secondary Outcomes (3)

• perioperative time

  from the operation beginning to end

• Adverse events

  in the process of the operation

• Patient satisfaction rate

  One day after the operation

Study Arms (2)

FB with fentanyl

EXPERIMENTAL

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

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

Drug: Midazolam; Drug: Propofol; Device: Bispectral Index monitoring

Interventions

Fentanyl DRUG

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

Also known as: fentanest, fantail, sublimaze

FB with fentanyl

Midazolam DRUG

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

Also known as: Ro-21-3981

FB with fentanyl; FB without fentanyl

Propofol DRUG

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

Also known as: diprivan, disoprofol

FB with fentanyl; FB without fentanyl

Bispectral Index monitoring DEVICE

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

FB with fentanyl; FB without fentanyl

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cough reflex is good agree to do bronchoscopy agree to take part in the study no the contraindication of bronchoscopy

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Related Publications (2)

• 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.

  PMID: 19443532 RESULT

• 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.

  PMID: 22045879 RESULT

Related Links

• Titrated sedation with propofol or midazolam for flexible bronchoscopy: a randomised trial.
• American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients.

MeSH Terms

Conditions

Lung Diseases

Interventions

Fentanyl; Midazolam; Propofol

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• wei gu, master

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2017
• First Posted: January 10, 2018
• Study Start: July 21, 2016
• Primary Completion: June 30, 2018
• Study Completion: December 31, 2018
• Last Updated: January 10, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share