BronchoscopyNCT03983889
Sedation Strategies for Diagnostic Bronchoscopy 2
A study testing Midazolam, Fentanyl and Dexmedetomidine in people with Bronchoscopy and Sedation, run by Changhai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bronchoscopy, Sedation
- What is being tested?
- Midazolam, Fentanyl and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Faculty of Anesthesiology, Changhai Hospital
Shanghai, Shanghai Municipality, 200433
About this study
Official title: 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.
- Conditions
- Bronchoscopy, Sedation
- Being tested
- Midazolam, Fentanyl, Dexmedetomidine, Remifentanil, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Midazolam is used as a common medication for sedation in all groups.
FentanylDrug
Fentanyl is another opioid drug used for analgesia to prevent bronchoscopy induced cough.
DexmedetomidineDrug
Dexmedetomidine is used for sedation in bronchoscopy with less impact on respiration.
RemifentanilDrug
Remifentanil is used for analgesia to prevent bronchoscopy induced cough.
PropofolDrug
Propofol is used for sedation with high efficacy but more side effect on respiration than dexmedetomidine.
| Study group | Role | What they receive |
|---|---|---|
| F | Experimental | Sedated with intravenous midazolam (0.03mg/kg) and fentanyl (1μg/kg) for induction and maintenance Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Midazolam; Drug: Remifentanil; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours
Secondary outcomes (5)
Body movement
The numbers of the times of any body movement across the procedure
Measured: 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
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. The scale score was determined by the subjective determination of the satisfaction on the sedation quality.
Measured: Across the procedure, assessed up to 2 hours
Amount of the rescue use of propofol
The total amount of propofol used as a rescue therapy when the sedation is not deep enough as assessed by the anesthesiologists.
Measured: After sedation induction, assessed up to 2 hours
Recovery time
Duration of the recovery from sedation
Measured: After termination of the sedation medication, assessed up to 2 hours
Prevalence of the side effects of respiratory and circulatory system
The number of the side effects in respiratory and circulatory system during the procedure, including hypertension, hypotension, tachycardia, bradycardia, hypoxia and larynx spasm.
Measured: Across the sedation duration, assessed up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start17 Jun 2019 (estimated)
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Ruijin Hospital, Shanghai Pulmonary Hospital, Shanghai, China
- Responsible party
- Principal investigator, Jia-feng Wang, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983889
- Sponsor's protocol ID
- SED-DFB2
- Status last verified
- Jun 2019
- First submitted
- 10 Jun 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Safety of Different Sedation Strategies for Diagnostic Bronchoscopy
- ClinicalTrials.gov ID
- NCT03983889
- Acronym / sponsor ID
- SED-DFB2
- Conditions
- Bronchoscopy, Sedation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Ruijin Hospital, Shanghai Pulmonary Hospital, Shanghai, China
- Study start
- 17 Jun 2019 (estimated)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| F | Experimental | Drug: Midazolam, Drug: FentanylSedated with intravenous midazolam (0.03mg/kg) and fentanyl (1μg/kg) for induction and maintenance |
| DR | Experimental | Drug: Midazolam, Drug: Dexmedetomidine, Drug: RemifentanilSedated 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 |
| DF | Experimental | Drug: Midazolam, Drug: Fentanyl, Drug: DexmedetomidineSedated 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 |
| PR | Experimental | Drug: Midazolam, Drug: Remifentanil, Drug: PropofolSedated 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Severe airway obstruction
- Coagulation disorder
- Repeat bronchoscopy (more than 3 times)
- Severe liver and renal dysfunction
- Cardiovascular and cerebrovascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamMidazolam is used as a common medication for sedation in all groups. | Drug | DF, DR, F, PR |
| FentanylFentanyl is another opioid drug used for analgesia to prevent bronchoscopy induced cough. | Drug | DF, F |
| DexmedetomidineDexmedetomidine is used for sedation in bronchoscopy with less impact on respiration. | Drug | DF, DR |
| RemifentanilRemifentanil is used for analgesia to prevent bronchoscopy induced cough. | Drug | DR, PR |
| PropofolPropofol is used for sedation with high efficacy but more side effect on respiration than dexmedetomidine. | Drug | PR |
Primary outcome
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
5 secondary outcomes
Body movement
Time frame: 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
Time frame: Across the procedure, assessed up to 2 hours
Amount of the rescue use of propofol
Time frame: After sedation induction, assessed up to 2 hours
Recovery time
Time frame: After termination of the sedation medication, 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam, Fentanyl and Dexmedetomidine in people with Bronchoscopy and Sedation, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia-feng Wang, MD (+862131161869, jfwang@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough score (time frame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019; AzTrials last refreshed its copy on 31 Oct 2026.