- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03406533
Sedation Strategies for Diagnostic Bronchoscopy
June 10, 2019 updated by: Jia-feng Wang, Changhai Hospital
The Effect and Safety of Different Sedation Strategies for Diagnostic Bronchoscopy
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200433
- Faculty of Anesthesiology, Changhai Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group F
Sedated with midazolam and fentanyl
|
Midazolam is used as a common medication for sedation in all groups.
Fentanyl is another opioid drug used for analgesia to prevent bronchoscopy induced cough.
|
EXPERIMENTAL: Group DR
Sedated with midazolam, dexmedetomidine and remifentanil
|
Midazolam is used as a common medication for sedation in all groups.
Dexmedetomidine is used for sedation in bronchoscopy with less impact on respiration.
Remifentanil is used for analgesia to prevent bronchoscopy induced cough.
|
EXPERIMENTAL: Group DF
Sedated with midazolam, dexmedetomidine and fentanyl
|
Midazolam is used as a common medication for sedation in all groups.
Fentanyl is another opioid drug used for analgesia to prevent bronchoscopy induced cough.
Dexmedetomidine is used for sedation in bronchoscopy with less impact on respiration.
|
EXPERIMENTAL: Group PR
Sedated with midazolam, propofol and remifentanil
|
Midazolam is used as a common medication for sedation in all groups.
Remifentanil is used for analgesia to prevent bronchoscopy induced cough.
Propofol is used for sedation with high efficacy but more side effect on respiration than dexmedetomidine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cough score
Time Frame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recovery time
Time Frame: After termination of the sedation medication, assessed up to 2 hours
|
Duration of the recovery from sedation
|
After termination of the sedation medication, assessed up to 2 hours
|
Body movement
Time Frame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours
|
The numbers of the times of any body movement across the procedure
|
From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours
|
Amount of the rescue use of propofol
Time Frame: After sedation induction, assessed up to 2 hours
|
The total amount of propofol used as a rescue therapy when the sedation is not deep enough as assessed by the anesthesiologists.
|
After sedation induction, assessed up to 2 hours
|
Satisfaction score of the patients and bronchoscopists
Time Frame: Across the procedure, assessed up to 2 hours
|
Satisfaction score of the patients and bronchoscopists regarding to the sedation quality measured by a 0-100 visual analogue scale (VAS).
100 refers to the highest satisfaction degree while 0 refers to the worst satisfaction degree.
|
Across the procedure, assessed up to 2 hours
|
Prevalence of the side effects of respiratory and circulatory system
Time Frame: Across the sedation duration, assessed up to 2 hours
|
The number of the side effects in respiratory and circulatory system during the procedure, including hypertension, hypotension, tackycardia, bradycardia, hypoxia and larynx spasm.
|
Across the sedation duration, assessed up to 2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2018
Primary Completion (ACTUAL)
March 30, 2018
Study Completion (ACTUAL)
March 31, 2018
Study Registration Dates
First Submitted
December 13, 2017
First Submitted That Met QC Criteria
January 15, 2018
First Posted (ACTUAL)
January 23, 2018
Study Record Updates
Last Update Posted (ACTUAL)
June 12, 2019
Last Update Submitted That Met QC Criteria
June 10, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Analgesics, Opioid
- Narcotics
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Remifentanil
- Fentanyl
- Midazolam
- Propofol
- Dexmedetomidine
Other Study ID Numbers
- SED-DFB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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