Drug UsagePhase 4NCT01931683
Dosing Study of Remifentanil for Smooth Removal of the Laryngeal Mask Airway (LMA)
A Phase 4 study testing remifentanil and laryngeal mask airway (LMA) in people with Drug Usage, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The investigators attempted to determine the optimal effect-site concentration of remifentanil for smooth removal of the LMA from propofol anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Drug Usage
- What is being tested?
- remifentanil and laryngeal mask airway (LMA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Feb 2014
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II patients undergoing general anesthesia for short elective surgery (<1 hr)
Who cannot join
- G-E reflux
- obesity (BMI>30)
- anticipated difficult airway
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect-site Concentration of Remifentanil for Smooth Removal of the LMA From Propofol Anesthesia
The investigators attempted to determine the optimal effect-site concentration of remifentanil for smooth removal of the LMA from propofol anesthesia.
Read the detailed description
At the end of the surgery, propofol infusion was stopped and remifentanil was titrated to predetermined (initial concentration 1.0 ng/ml for the first patient). LMA removal was performed when the patients opened their eyes and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed.
- Conditions
- Drug Usage
- Being tested
- remifentanil, laryngeal mask airway (LMA)
- Keywords
- LMA removal, remifentanil, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remifentanilDrug
Also called Ultiva
The concentration of remifentanil was determined by modified Dixon's up-and-down method, starting from 1.0 ng/ml (0.2 ng/ml as a step size)
laryngeal mask airway (LMA)Device
LMA was removed when the patients opened their eyes, and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed
| Study group | Role | What they receive |
|---|---|---|
| remifentanil | Experimental | LMA removal was accomplished when remifentanil was maintained a predetermined concentration throughout the emergence periods. Receives: Drug: remifentanil; Device: laryngeal mask airway (LMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
smooth removal of LMA
the response of patients to the removal of LMA (classified as either 'success [smooth emergence]' or 'failure') during infusion of remifentanil.
Measured: from end of surgery to removal of LMA (participants will be followed for the emergence periods, an expected average of 15 min).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug UsageStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Yeop Kim, Ajou University School of Medicine
- Investigators
- Jong Yeop Kim, MD, Study director, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931683
- Sponsor's protocol ID
- AJIRB-MED-CT4-13
- Status last verified
- Oct 2014
- First submitted
- 27 Aug 2013
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect-site Concentration of Remifentanil for Smooth Removal of the LMA From Propofol Anesthesia
- ClinicalTrials.gov ID
- NCT01931683
- Acronym / sponsor ID
- AJIRB-MED-CT4-13
- Conditions
- Drug Usage
- Keywords
- LMA removal, remifentanil, propofol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 29 Aug 2013 (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.
The investigators attempted to determine the optimal effect-site concentration of remifentanil for smooth removal of the LMA from propofol anesthesia.
Detailed description
At the end of the surgery, propofol infusion was stopped and remifentanil was titrated to predetermined (initial concentration 1.0 ng/ml for the first patient). LMA removal was performed when the patients opened their eyes and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| remifentanil | Experimental | Drug: remifentanil, Device: laryngeal mask airway (LMA)LMA removal was accomplished when remifentanil was maintained a predetermined concentration throughout the emergence periods. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I-II patients undergoing general anesthesia for short elective surgery (<1 hr)
Key exclusion criteria (3 listed)
- G-E reflux
- obesity (BMI>30)
- anticipated difficult 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 |
|---|---|---|
| remifentanilAlso: UltivaThe concentration of remifentanil was determined by modified Dixon's up-and-down method, starting from 1.0 ng/ml (0.2 ng/ml as a step size) | Drug | remifentanil |
| laryngeal mask airway (LMA)LMA was removed when the patients opened their eyes, and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed | Device | remifentanil |
Primary outcome
smooth removal of LMA
Time frame: from end of surgery to removal of LMA (participants will be followed for the emergence periods, an expected average of 15 min).
the response of patients to the removal of LMA (classified as either 'success [smooth emergence]' or 'failure') during infusion of remifentanil.
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 15 Oct 2014.
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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.
Jong Yeop Kim, MD study director
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 remifentanil and laryngeal mask airway (LMA) in people with Drug Usage, 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 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 15 Oct 2014. 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.
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?
smooth removal of LMA (time frame: from end of surgery to removal of LMA (participants will be followed for the emergence periods, an expected average of 15 min).). 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 15 Oct 2014.