Sedation Strategies for Diagnostic Bronchoscopy 2

NCT ID: NCT03983889

Last Updated: 2019-06-14

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchoscopy Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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F

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

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

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

Fentanyl

Intervention Type DRUG

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

DR

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

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

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

Dexmedetomidine

Intervention Type DRUG

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

Remifentanil

Intervention Type DRUG

Remifentanil is used for analgesia to prevent bronchoscopy induced cough.

DF

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

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

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

Fentanyl

Intervention Type DRUG

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

Dexmedetomidine

Intervention Type DRUG

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

PR

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

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

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

Remifentanil

Intervention Type DRUG

Remifentanil is used for analgesia to prevent bronchoscopy induced cough.

Propofol

Intervention Type DRUG

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

Interventions

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Midazolam

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

Intervention Type DRUG

Fentanyl

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

Intervention Type DRUG

Dexmedetomidine

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

Intervention Type DRUG

Remifentanil

Remifentanil is used for analgesia to prevent bronchoscopy induced cough.

Intervention Type DRUG

Propofol

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jia-feng Wang

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Anesthesiology, Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Jia-feng Wang, MD

Role: CONTACT

+862131161869

Xiao-ming Deng, MD

Role: CONTACT

+862131161837

Other Identifiers

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SED-DFB2

Identifier Type: -

Identifier Source: org_study_id

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