Safety IssuesNCT04169685
Dexmedetomidine for Sedation Undergoing Bronchoscopy
An observational study of Safety Issues, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
Several sedatives or analgesics can be used to achieve appropriate levels of sedation for endoscopic procedures. Dexmedetomide is notable for providing sedation without respiratory depression. We hypothesized dexmedetomide is more suitable for sedation of bronchoscopy than other sedative drugs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Safety Issues
- What is being tested?
- bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2017to 31 Jul 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients undergoing flexible bronchoscopy
Who may be able to join
- sedation undergoing flexible bronchoscopy
Who cannot join
- without sedation undergoing flexible bronchoscopy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City
sheng hua wu, MD, PHD, 886-7-3121101 ext. 7035, elsawu2@gmail.com
About this study
Official title: Comparison of Dexmedetomidine and Propofol for Sedation in Adult Patients Undergoing Flexible Bronchoscopy -A Retrospective Review
Several sedatives or analgesics can be used to achieve appropriate levels of sedation for endoscopic procedures. Dexmedetomide is notable for providing sedation without respiratory depression. We hypothesized dexmedetomide is more suitable for sedation of bronchoscopy than other sedative drugs.
Read the detailed description
A retrospective chart review was conducted. All patients undergoing flexible bronchoscopy with moderate sedation were enrolled.The primary analysis outcome was safety profile during procedure included incidence of procedure interruption, incidence of snoring and observed apnea, transient hypoxemia and hypotension. The secondary outcome was measured by recovery profile (awake and ambulation time).
- Conditions
- Safety Issues
- Being tested
- bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoscopyProcedure or surgery
during flexible bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| with dexmedetomidine | Drugs provided moderate sedation during procedure including dexmedetomidine Receives: Procedure: bronchoscopy | |
| without dexmedetomidine | Drugs provided moderate sedation during procedure without dexmedetomidine Receives: Procedure: bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety profile during procedure
Incidence of procedure interruption, incidence of snoring and observed apnea, transient hypoxemia and hypotension
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Apr 2017
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Hua Wu, Kaohsiung Medical University
- Investigators
- sheng hua wu, MD, PHD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169685
- Sponsor's protocol ID
- KMUHIRB-E(I)-20190221
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dexmedetomidine and Propofol for Sedation in Adult Patients Undergoing Flexible Bronchoscopy -A Retrospective Review
- ClinicalTrials.gov ID
- NCT04169685
- Acronym / sponsor ID
- KMUHIRB-E(I)-20190221
- Conditions
- Safety Issues
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 20 Nov 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.
Several sedatives or analgesics can be used to achieve appropriate levels of sedation for endoscopic procedures. Dexmedetomide is notable for providing sedation without respiratory depression. We hypothesized dexmedetomide is more suitable for sedation of bronchoscopy than other sedative drugs.
Detailed description
A retrospective chart review was conducted. All patients undergoing flexible bronchoscopy with moderate sedation were enrolled.The primary analysis outcome was safety profile during procedure included incidence of procedure interruption, incidence of snoring and observed apnea, transient hypoxemia and hypotension. The secondary outcome was measured by recovery profile (awake and ambulation time).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with dexmedetomidine | – | Procedure: bronchoscopyDrugs provided moderate sedation during procedure including dexmedetomidine |
| without dexmedetomidine | – | Procedure: bronchoscopyDrugs provided moderate sedation during procedure without dexmedetomidine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients undergoing flexible bronchoscopy
Key inclusion criteria (1 listed)
- sedation undergoing flexible bronchoscopy
Key exclusion criteria (1 listed)
- without sedation undergoing flexible bronchoscopy
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 |
|---|---|---|
| bronchoscopyduring flexible bronchoscopy | Procedure or surgery | with dexmedetomidine, without dexmedetomidine |
Primary outcome
safety profile during procedure
Time frame: during procedure
Incidence of procedure interruption, incidence of snoring and observed apnea, transient hypoxemia and hypotension
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Individual participant dataSharing planned: No
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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.
sheng hua wu, MD, PHD principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety Issues, run by Kaohsiung Medical University at 1 site in Taiwan.
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 1 inclusion and 1 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 20 Nov 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 Taiwan. 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 sheng hua sheng hua, MD, PHD (886-7-3121101 ext. 7035, elsawu2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety profile during procedure (time frame: during procedure). 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 20 Nov 2019.