Anesthesia, SpinalNCT02993718
Sedation by Dexmedetomidine and Propofol
A study testing Dexmedetomidine and Propofol in people with Anesthesia, Spinal, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Under the hypothesis that dexmedetomidine sedation would result in less upper airway obstruction, we evaluated the occurrence of upper airway collapse or the requirement of airway intervention in patients with obstructive sleep apnea during dexmedetomidine or propofol sedation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anesthesia, Spinal
- What is being tested?
- Dexmedetomidine and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Jun 2017
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgery under spinal anesthesia
- Intraoperative sedation
- American Society of Anesthesiology physical status 1 or 2
- Apnea/hypopnea index 5-14/h in Watch-PAT 200 analysis
Who cannot join
- Anatomical defects on upper respiratory tract
- Psychotic disorder
- Drug addition
- Alcohol addition
- body mass index ≥ 35 kg/m2
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Comparison of the Upper Airway Patency by Dexmedetomidine and Propofol Used for Sedation
Under the hypothesis that dexmedetomidine sedation would result in less upper airway obstruction, we evaluated the occurrence of upper airway collapse or the requirement of airway intervention in patients with obstructive sleep apnea during dexmedetomidine or propofol sedation.
- Conditions
- Anesthesia, Spinal
- Being tested
- Dexmedetomidine, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
As a loading dose, 0.5 μg/kg dexmedetomidine was administered over 10 min, which was then administered continuously at a dose of 0.2-0.8 μg/kg/h. Sedation was maintained at modified observer's assessment of alertness/sedation scale 3
PropofolDrug
Propofol was infused continuously via a target-controlled infusion device, and the effect-site concentration was maintained with a range of 0.5-2.0 μg/ml. Sedation was maintained at modified observer's assessment of alertness/sedation scale 3
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Intraoperative sedation is performed by using dexmedetomidine. Receives: Drug: Dexmedetomidine |
| Propofol | Experimental | Intraoperative sedation is performed by using propofol Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of upper airway obstruction
When end-tidal carbon dioxide was not detected in spite of the respiratory effort during the sedation period, the case will be regarded as the occurrence of upper airway obstruction.
Measured: During the sedation period, an average of 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, SpinalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993718
- Sponsor's protocol ID
- WatchPAT
- Status last verified
- Sep 2017
- First submitted
- 11 Dec 2016
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Shin HJ, Kim EY, Hwang JW, Do SH, Na HS. Comparison of upper airway patency in patients with mild obstructive sleep apnea during dexmedetomidine or propofol sedation: a prospective, randomized, controlled trial. BMC Anesthesiol. 2018 Sep 5;18(1):120. doi: 10.1186/s12871-018-0586-5.
PubMed 30185146
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Upper Airway Patency by Dexmedetomidine and Propofol Used for Sedation
- ClinicalTrials.gov ID
- NCT02993718
- Acronym / sponsor ID
- WatchPAT
- Conditions
- Anesthesia, Spinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 15 Dec 2016 (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.
Under the hypothesis that dexmedetomidine sedation would result in less upper airway obstruction, we evaluated the occurrence of upper airway collapse or the requirement of airway intervention in patients with obstructive sleep apnea during dexmedetomidine or propofol sedation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidineIntraoperative sedation is performed by using dexmedetomidine. |
| Propofol | Experimental | Drug: PropofolIntraoperative sedation is performed by using propofol |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Surgery under spinal anesthesia
- Intraoperative sedation
- American Society of Anesthesiology physical status 1 or 2
- Apnea/hypopnea index 5-14/h in Watch-PAT 200 analysis
Key exclusion criteria (5 listed)
- Anatomical defects on upper respiratory tract
- Psychotic disorder
- Drug addition
- Alcohol addition
- body mass index ≥ 35 kg/m2
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 |
|---|---|---|
| DexmedetomidineAs a loading dose, 0.5 μg/kg dexmedetomidine was administered over 10 min, which was then administered continuously at a dose of 0.2-0.8 μg/kg/h. Sedation was maintained at modified observer's assessment of alertness/sedation scale 3 | Drug | Dexmedetomidine |
| PropofolPropofol was infused continuously via a target-controlled infusion device, and the effect-site concentration was maintained with a range of 0.5-2.0 μg/ml. Sedation was maintained at modified observer's assessment of alertness/sedation scale 3 | Drug | Propofol |
Primary outcome
The occurrence of upper airway obstruction
Time frame: During the sedation period, an average of 3 hours.
When end-tidal carbon dioxide was not detected in spite of the respiratory effort during the sedation period, the case will be regarded as the occurrence of upper airway obstruction.
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 14 Sep 2017.
- Derived from this study: PubMed 30185146Shin HJ, Kim EY, Hwang JW, Do SH, Na HS. Comparison of upper airway patency in patients with mild obstructive sleep apnea during dexmedetomidine or propofol sedation: a prospective, randomized, controlled trial. BMC Anesthesiol. 2018 Sep 5;18(1):120. doi: 10.1186/s12871-018-0586-5.
- 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.
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 and Propofol in people with Anesthesia, Spinal, run by Seoul National University Bundang Hospital 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 4 inclusion and 5 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 14 Sep 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?
The occurrence of upper airway obstruction (time frame: During the sedation period, an average of 3 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02993718, which also lists 1 linked publication.
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 Sep 2017.