BronchoscopyNCT03406546
Sedation Strategies for Therapeutic Bronchoscopy
A study testing Dexmedetomidine, Remifentanil and Laryngeal mask in people with Bronchoscopy and Sedation, run by Changhai Hospital at 1 site in China.
Trial summary
Therapeutic bronchoscopy is a common procedure to treat respiratory diseases. The procedure includes stent implantation, bronchus dilation, electronic incision, laser therapy, and so on. Most of these procedures are painful and require general anesthesia. 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?
- Dexmedetomidine, Remifentanil and Laryngeal mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 31 Jul 2018
- 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 therapeutic 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: Comparison of Sedation and General Anesthesia With Laryngeal Mask in Therapeutic Bronchoscopy
Therapeutic bronchoscopy is a common procedure to treat respiratory diseases. The procedure includes stent implantation, bronchus dilation, electronic incision, laser therapy, and so on. Most of these procedures are painful and require general anesthesia. Conventionally, the general anesthesia for therapeutic bronchoscopy was performed using laryngeal mask. But in the previous experiences, the investigators found that sedation with dexmedetomidine and remifentanil was as effect as laryngeal mask anesthesia. The present study was performed to compare the two approach for sedation or anesthesia in therapeutic bronchoscopy.
- Conditions
- Bronchoscopy, Sedation
- Being tested
- Dexmedetomidine, Remifentanil, Laryngeal mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine was used as a sedation agent with less side effect on respiratory system.
RemifentanilDrug
Remifentanil was used to prevent cough induced by bronchoscopy.
Laryngeal maskDevice
Laryngeal mask was used to ensure respiration function during general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group DR | Experimental | Patients sedated with dexmedetomidine and remifentanil. Receives: Drug: Dexmedetomidine; Drug: Remifentanil |
| Group LMA | Experimental | General anesthesia was applied using laryngeal mask. Receives: Device: Laryngeal mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time
Duration of the recovery from sedation
Measured: After termination of the sedation medication, assessed up to 3 hours
Secondary outcomes (5)
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.
Measured: Across the procedure, assessed up to 3 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, tackycardia, bradycardia, hypoxia and larynx spasm.
Measured: Across the sedation or anesthesia, assessed up to 3 hours
Cost of anesthesia or sedation
Measured: Across the sedation or anesthesia, assessed up to 3 hours
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 3 hours
The numbers of the times of 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 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Feb 2018
- Primary completion30 Jun 2018
- Study completion31 Jul 2018
Why it stopped: The sample size should be re-calculated based on the first 20 cases.
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
- None (open label)
- Enrolment
- 20 participants (actual)
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
- NCT03406546
- Sponsor's protocol ID
- SED-TFB
- Status last verified
- Jun 2019
- First submitted
- 13 Dec 2017
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sedation and General Anesthesia With Laryngeal Mask in Therapeutic Bronchoscopy
- ClinicalTrials.gov ID
- NCT03406546
- Acronym / sponsor ID
- SED-TFB
- Conditions
- Bronchoscopy, Sedation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sample size should be re-calculated based on the first 20 cases.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Ruijin Hospital, Shanghai Pulmonary Hospital, Shanghai, China
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 23 Jan 2018 (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.
Therapeutic bronchoscopy is a common procedure to treat respiratory diseases. The procedure includes stent implantation, bronchus dilation, electronic incision, laser therapy, and so on. Most of these procedures are painful and require general anesthesia. Conventionally, the general anesthesia for therapeutic bronchoscopy was performed using laryngeal mask. But in the previous experiences, the investigators found that sedation with dexmedetomidine and remifentanil was as effect as laryngeal mask anesthesia. The present study was performed to compare the two approach for sedation or anesthesia in therapeutic bronchoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group DR | Experimental | Drug: Dexmedetomidine, Drug: RemifentanilPatients sedated with dexmedetomidine and remifentanil. |
| Group LMA | Experimental | Device: Laryngeal maskGeneral anesthesia was applied using laryngeal mask. |
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 therapeutic 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 |
|---|---|---|
| DexmedetomidineDexmedetomidine was used as a sedation agent with less side effect on respiratory system. | Drug | Group DR |
| RemifentanilRemifentanil was used to prevent cough induced by bronchoscopy. | Drug | Group DR |
| Laryngeal maskLaryngeal mask was used to ensure respiration function during general anesthesia. | Device | Group LMA |
Primary outcome
Recovery time
Time frame: After termination of the sedation medication, assessed up to 3 hours
Duration of the recovery from sedation
5 secondary outcomes
Satisfaction score of the patients and bronchoscopists
Time frame: Across the procedure, assessed up to 3 hours
Prevalence of the side effects of respiratory and circulatory system
Time frame: Across the sedation or anesthesia, assessed up to 3 hours
Cost of anesthesia or sedation
Time frame: Across the sedation or anesthesia, assessed up to 3 hours
Cough score
Time frame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 hours
The numbers of the times of body movement
Time frame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 hours
Results and safety
The study was stopped early (reason given: The sample size should be re-calculated based on the first 20 cases.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Remifentanil and Laryngeal mask 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: stopped early, as of the sponsor's last update on 12 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?
The study was stopped early (reason given: The sample size should be re-calculated based on the first 20 cases.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery time (time frame: After termination of the sedation medication, assessed up to 3 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 12 Jun 2019; AzTrials last refreshed its copy on 31 Oct 2026.