Sleep Apnea SyndromeNCT02148432
Establishment of Ideal IV Sedative Regimen for Successful Fiberoptic Bronchoscopy in Assessing the Site, Severity of Sleep Apnea Syndrome
A study testing dexmedetomidine infusion rate, 0.5 mcg/kg/hr and dexmedetomidine infusion rate, 1.0 mcg/kg/hr in people with Sleep Apnea Syndrome, run by Yonsei University at 1 site in South Korea.
Trial summary
Venous thromboembolism(VTE) is the third most common cardiovascular complication among hospitalized patients, and can even cause death. VTE often occurs in intensive care patients and there had been many efforts to prevent such complication. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea Syndrome
- What is being tested?
- dexmedetomidine infusion rate, 0.5 mcg/kg/hr and dexmedetomidine infusion rate, 1.0 mcg/kg/hr
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 May 2014to 29 Apr 2016
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-60 years old patients with ASA class I-II
- Scheduled for drug induced sleep endoscope after diagnosed with sleep apnea syndrome
Who cannot join
- Patients having hearing difficulties, taking any CNS related medication, history of any adverse drug reaction, Glasgow coma scale < 15
- Patients with severe cardiopulmonary dysfunction
- Patients refusal
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
Venous thromboembolism(VTE) is the third most common cardiovascular complication among hospitalized patients, and can even cause death. VTE often occurs in intensive care patients and there had been many efforts to prevent such complication. The American College of Chest Physicians (ACCP) had published evidence-based clinical practice guideline for VTE prophylaxis.
This study focuses on how VTE prophylaxis is being performed in both medical and surgical ICUs in a single University hospital, and sees the differences in such prophylactic patterns.
- Conditions
- Sleep Apnea Syndrome
- Being tested
- dexmedetomidine infusion rate, 0.5 mcg/kg/hr, dexmedetomidine infusion rate, 1.0 mcg/kg/hr
- Keywords
- sleep apnea syndrome, fiberoptic bronchoscopy, IV sedation
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine infusion rate, 0.5 mcg/kg/hrDrug
continuous infusion of dexmedetomidine at rate of 0.5 mcg/kg/hr
dexmedetomidine infusion rate, 1.0 mcg/kg/hrDrug
continuous infusion of dexmedetomidine at rate of 1.0 mcg/kg/hr
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine 0.5 mcg/kg/hr | Experimental | Not described Receives: Drug: dexmedetomidine infusion rate, 0.5 mcg/kg/hr |
| dexmedetomidine 1.0 mcg/kg/hr | Active comparator | Not described Receives: Drug: dexmedetomidine infusion rate, 1.0 mcg/kg/hr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desaturation rate
SpO2 < 90% (checked by pulse oximetry)
Measured: Baseline from 5 min after remifentanil TCI start, 10 min after dexmedetomidine loading start, every 5 min until surgeon can do endoscopy successfully, to immediately after endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study start19 May 2014
- Primary completion29 Apr 2016
- Study completion29 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148432
- Sponsor's protocol ID
- 4-2014-0232
- Status last verified
- Jan 2017
- First submitted
- 22 May 2014
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Ideal IV Sedative Regimen for Successful Fiberoptic Bronchoscopy in Assessing the Site, Severity of Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT02148432
- Acronym / sponsor ID
- 4-2014-0232
- Conditions
- Sleep Apnea Syndrome
- Keywords
- sleep apnea syndrome, fiberoptic bronchoscopy, IV sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 19 May 2014 (actual)
- Primary completion
- 29 Apr 2016 (actual)
- Study completion
- 29 Apr 2016 (actual)
- First posted
- 28 May 2014 (estimated)
- 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.
Venous thromboembolism(VTE) is the third most common cardiovascular complication among hospitalized patients, and can even cause death. VTE often occurs in intensive care patients and there had been many efforts to prevent such complication. The American College of Chest Physicians (ACCP) had published evidence-based clinical practice guideline for VTE prophylaxis.
This study focuses on how VTE prophylaxis is being performed in both medical and surgical ICUs in a single University hospital, and sees the differences in such prophylactic patterns.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine 0.5 mcg/kg/hr | Experimental | Drug: dexmedetomidine infusion rate, 0.5 mcg/kg/hr |
| dexmedetomidine 1.0 mcg/kg/hr | Active comparator | Drug: dexmedetomidine infusion rate, 1.0 mcg/kg/hr |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 20-60 years old patients with ASA class I-II
- Scheduled for drug induced sleep endoscope after diagnosed with sleep apnea syndrome
Key exclusion criteria (3 listed)
- Patients having hearing difficulties, taking any CNS related medication, history of any adverse drug reaction, Glasgow coma scale < 15
- Patients with severe cardiopulmonary dysfunction
- Patients refusal
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 |
|---|---|---|
| dexmedetomidine infusion rate, 0.5 mcg/kg/hrcontinuous infusion of dexmedetomidine at rate of 0.5 mcg/kg/hr | Drug | dexmedetomidine 0.5 mcg/kg/hr |
| dexmedetomidine infusion rate, 1.0 mcg/kg/hrcontinuous infusion of dexmedetomidine at rate of 1.0 mcg/kg/hr | Drug | dexmedetomidine 1.0 mcg/kg/hr |
Primary outcome
Desaturation rate
Time frame: Baseline from 5 min after remifentanil TCI start, 10 min after dexmedetomidine loading start, every 5 min until surgeon can do endoscopy successfully, to immediately after endoscopy
SpO2 < 90% (checked by pulse oximetry)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
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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 infusion rate, 0.5 mcg/kg/hr and dexmedetomidine infusion rate, 1.0 mcg/kg/hr in people with Sleep Apnea Syndrome, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 25 Jan 2017. 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 South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Desaturation rate (time frame: Baseline from 5 min after remifentanil TCI start, 10 min after dexmedetomidine loading start, every 5 min until surgeon can do endoscopy successfully, to immediately after endoscopy). 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 25 Jan 2017.