Precedex Effect to Propofol RequirementPhase 4NCT02284672
The Effect of Dexmedetomidine on Propofol Requirement for Insertion of Laryngeal Mask Airway
A Phase 4 study testing Dexmedetomidine and Normal saline in people with Precedex Effect to Propofol Requirement, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Propofol frequently used as an inducting medication for insertion Laryngeal mask airway(LMA). But propofol alone can be not sufficient for inhibiting upper airway reflex and also result in cardiovascular suppression under enough amount. Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Precedex Effect to Propofol Requirement
- What is being tested?
- Dexmedetomidine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Jan 2016
- Phase
- Phase 4
- 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients for surgery not exceed more than 2 hours requiring general anesthesia
Who cannot join
- history of gastroesophageal reflux High grade obesity Predicted diffiicult airway
Trial locations and contacts
1 site in 1 country.
About this study
Propofol frequently used as an inducting medication for insertion Laryngeal mask airway(LMA). But propofol alone can be not sufficient for inhibiting upper airway reflex and also result in cardiovascular suppression under enough amount. Dexmedetomidine is a selective alplh2 receptor agonist with analgesic and sedative effects but sparing respiratory function. Therefore propofol combined with dexmedetomidine induction could be more effective in preserve respiration under same condition for LMA insertion than propofol alone. In this study, the investigators investigate the clinical dose of propofol for LMA insertion with premedication of dexmedetomidine, and evaluate the effect of dexmedetomidine.
- Conditions
- Precedex Effect to Propofol Requirement
- Being tested
- Dexmedetomidine, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | After preoxygenation for 3 minutes, normal saline would be injected to patient for 10 minute. First, 1% lidocaine 3 ml were given for reducing injection pain of propofol and the settled amount of propofol was injected during 15 seconds.
After 90 seconds, other anesthesiologist who did'nt know the injected drug tried to insert LMA. Receives: Drug: Normal saline |
| dexmedetomidine | Experimental | After preoxygenation for 3 minutes, dexmedetomidine would be injected to patient for 10 minute. First, 1% lidocaine 3 ml were given for reducing injection pain of propofol and the settled amount of propofol was injected during 15 seconds.
After 90 seconds, other anesthesiologist who did'nt know the injected drug tried to insert LMA. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fail or success for Laryngeal Mask Airway (LMA) insertion
Failure for LMA insertion is defined if there is a difficulty for mouth opening or active movement of four limbs or head. Success is smooth LMA insertion without any movement
Measured: During inserting LMA and up to 5 seconds after LMA inserion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precedex Effect to Propofol RequirementStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiyoung Yoo, Ajou University School of Medicine
- Investigators
- Ji Young Yoo, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284672
- Sponsor's protocol ID
- AJIRB-MED-CT4-14-296
- Status last verified
- Feb 2016
- First submitted
- 4 Nov 2014
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on Propofol Requirement for Insertion of Laryngeal Mask Airway
- ClinicalTrials.gov ID
- NCT02284672
- Acronym / sponsor ID
- AJIRB-MED-CT4-14-296
- Conditions
- Precedex Effect to Propofol Requirement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Nov 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.
Propofol frequently used as an inducting medication for insertion Laryngeal mask airway(LMA). But propofol alone can be not sufficient for inhibiting upper airway reflex and also result in cardiovascular suppression under enough amount. Dexmedetomidine is a selective alplh2 receptor agonist with analgesic and sedative effects but sparing respiratory function. Therefore propofol combined with dexmedetomidine induction could be more effective in preserve respiration under same condition for LMA insertion than propofol alone. In this study, the investigators investigate the clinical dose of propofol for LMA insertion with premedication of dexmedetomidine, and evaluate the effect of dexmedetomidine.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Drug: Normal salineAfter preoxygenation for 3 minutes, normal saline would be injected to patient for 10 minute. First, 1% lidocaine 3 ml were given for reducing injection pain of propofol and the settled amount of propofol was injected during 15 seconds. After 90 seconds, other anesthesiologist who did'nt know the injected drug tried to insert LMA. |
| dexmedetomidine | Experimental | Drug: DexmedetomidineAfter preoxygenation for 3 minutes, dexmedetomidine would be injected to patient for 10 minute. First, 1% lidocaine 3 ml were given for reducing injection pain of propofol and the settled amount of propofol was injected during 15 seconds. After 90 seconds, other anesthesiologist who did'nt know the injected drug tried to insert LMA. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients for surgery not exceed more than 2 hours requiring general anesthesia
Key exclusion criteria (1 listed)
- history of gastroesophageal reflux High grade obesity Predicted diffiicult airway
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 | Drug | dexmedetomidine |
| Normal saline | Drug | control |
Primary outcome
Fail or success for Laryngeal Mask Airway (LMA) insertion
Time frame: During inserting LMA and up to 5 seconds after LMA inserion
Failure for LMA insertion is defined if there is a difficulty for mouth opening or active movement of four limbs or head. Success is smooth LMA insertion without any movement
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 29 Feb 2016.
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.
Ji Young Yoo, MD principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Normal saline in people with Precedex Effect to Propofol Requirement, run by Ajou University School of Medicine 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 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: finished, as of the sponsor's last update on 29 Feb 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fail or success for Laryngeal Mask Airway (LMA) insertion (time frame: During inserting LMA and up to 5 seconds after LMA inserion). 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 29 Feb 2016.