Sedation Strategies for Diagnostic Bronchoscopy 2

NCT03983889 | Unknown

• 1 other identifier: SED-DFB2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Diagnostic bronchoscopy is an invasive procedure performed to diagnose respiratory diseases. But pain has been complained by most of the patients receiving such procedures. Sedation or anesthesia was required by both of the patients and bronchoscopists. Unfortunately, no consensus has been made upon the sedation strategies. Multiple sedation approaches have been applied, such as midazolam and fentanyl, remifentanil and propofol, dexmedetomidine and propofol. The present study was designed to compare these protocols in sedation for diagnostic bronchoscopy.

Conditions

Bronchoscopy; Sedation

Outcome Measures

Primary Outcomes (1)

• Cough score

  Cough score across the procedure will be classified into 4 degree (1-4) as follows. 1 = none, 2 = one gag or cough only, 3 = \>1 gag or cough, but acceptable conditions, 4 = unacceptable conditions

  From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours

Secondary Outcomes (5)

• Body movement

  From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours

• Satisfaction score of the patients and bronchoscopists

  Across the procedure, assessed up to 2 hours

• Amount of the rescue use of propofol

  After sedation induction, assessed up to 2 hours

• Recovery time

  After termination of the sedation medication, assessed up to 2 hours

• Prevalence of the side effects of respiratory and circulatory system

  Across the sedation duration, assessed up to 2 hours

Study Arms (4)

F

EXPERIMENTAL

Sedated with intravenous midazolam (0.03mg/kg) and fentanyl (1μg/kg) for induction and maintenance

Drug: Midazolam; Drug: Fentanyl

DR

EXPERIMENTAL

Sedated with intravenous midazolam (0.03mg/kg), dexmedetomidine (0.5-1μg/kg for induction+0.5-0.7μg/kg/h for maintenance) and remifentanil (plasma concentration 2.0-2.5ng/ml) for induction and maintenance

Drug: Midazolam; Drug: Dexmedetomidine; Drug: Remifentanil

DF

EXPERIMENTAL

Sedated with intravenous midazolam (0.03mg/kg), dexmedetomidine (0.5-1μg/kg for induction+0.5-0.7μg/kg/h for maintenance) and fentanyl (1μg/kg) for induction and maintenance

Drug: Midazolam; Drug: Fentanyl; Drug: Dexmedetomidine

PR

EXPERIMENTAL

Sedated with intravenous midazolam (0.03mg/kg), propofol (plasma concentration 1.0-2.0ng/ml) and remifentanil (plasma concentration 2.0-2.5ng/ml) for induction and maintenance

Drug: Midazolam; Drug: Remifentanil; Drug: Propofol

Interventions

Midazolam DRUG

Midazolam is used as a common medication for sedation in all groups.

DF; DR; F; PR

Fentanyl DRUG

Fentanyl is another opioid drug used for analgesia to prevent bronchoscopy induced cough.

DF; F

Dexmedetomidine DRUG

Dexmedetomidine is used for sedation in bronchoscopy with less impact on respiration.

DF; DR

Remifentanil DRUG

Remifentanil is used for analgesia to prevent bronchoscopy induced cough.

DR; PR

Propofol DRUG

Propofol is used for sedation with high efficacy but more side effect on respiration than dexmedetomidine.

PR

Eligibility Criteria

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

You may qualify if:

• Scheduled for flexible diagnostic bronchoscopy
• Adult patients aged 18 to 65 years
• American Society of Anesthesiologists (ASA) Physical Status Classification I-II
• BMI 18.5-25kg/m2
• Subjects provide informed consent

You may not qualify if:

• Severe airway obstruction
• Coagulation disorder
• Repeat bronchoscopy (more than 3 times)
• Severe liver and renal dysfunction
• Cardiovascular and cerebrovascular diseases
• Pregnancy
• Chronic opioid user
• Drug abusers or addicts

Sponsors & Collaborators

• Changhai Hospital: lead
• Shanghai Zhongshan Hospital: collaborator
• Ruijin Hospital: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator

Study Sites (1)

Faculty of Anesthesiology, Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Interventions

Midazolam; Fentanyl; Dexmedetomidine; Remifentanil; Propofol

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Imidazoles; Azoles; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Jia-feng Wang, MD

CONTACT

+862131161869; jfwang@smmu.edu.cn

Xiao-ming Deng, MD

CONTACT

+862131161837; deng_x@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 12, 2019
• Study Start: June 17, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: June 14, 2019

Record last verified: 2019-06

Locations

CN (1)