Supraglottic Airways for General AnesthesiaPhase 4NCT02382354
Remifentanil for the I-gel and Laryngeal Mask Airway Insertion
A Phase 4 study testing remifentanil, i-gel and laryngeal mask airway in people with Supraglottic Airways for General Anesthesia, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Structural differences of supraglottic airway devices could influence the different compressive forces in the oropharyngeal cavities, and require different depth of anesthesia. The addition of remifentanil during propofol anesthesia facilitates the insertion of laryngeal mask airway (LMA) with minimal adverse… Read more about this study
- Who is it for?
- Ages 19 to 60 years, women only
- Conditions the study is for
- Supraglottic Airways for General Anesthesia
- What is being tested?
- remifentanil, i-gel and laryngeal mask airway
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Sep 2015
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II patients undergoing general anesthesia for short elective surgery (<2 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: Comparison of the Effect-site Concentration of Remifentanil for Insertion of the I-gel and Laryngeal Mask Airway During Propofol Anesthesia
Structural differences of supraglottic airway devices could influence the different compressive forces in the oropharyngeal cavities, and require different depth of anesthesia. The addition of remifentanil during propofol anesthesia facilitates the insertion of laryngeal mask airway (LMA) with minimal adverse hemodynamic disturbances. This study was designed to determine the effect-site concentration of remifentanil in 50% of patients (EC50) and 95% of patients (EC95) for successful i- gel insertion, and compare those for LMA insertion during propofol target-controlled infusion (TCI).
Read the detailed description
Anesthesia was induced with propofol TCI at the effect-site concentration of 5 μg/ml, and the predetermined effect-site concentration of remifentanil was started simultaneously. The remifentanil concentration was determined using modified Dixon's up-and-down method (initial concentration: 3.0 ng/ml, step size: 0.5 ng/ml). Five minutes later, i- gel or LMA insertion was attempted. The response of the patients to the insertion of LMA was classified as either 'movement' or 'no movement'.
- Being tested
- remifentanil, i-gel, laryngeal mask airway, 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 predetermined effect-site concentration of remifentanil was started using modified Dixon's up-and-down method
i-gelDevice
I-gel insertion was inserted 5 min after anesthesia induction
laryngeal mask airwayDevice
laryngeal mask airway insertion was inserted 5 min after anesthesia induction
propofolDrug
Also called fresofol
Anesthesia was induced with propofol target-controlled infusion at the effect-site concentration of 5 μg/ml
| Study group | Role | What they receive |
|---|---|---|
| i-gel | Experimental | I-gel insertion was attempted during propofol and remifentanil anesthesia . Receives: Drug: remifentanil; Device: i-gel; Drug: propofol |
| laryngeal mask airway | Active comparator | LMA insertion was attempted during propofol and remifentanil anesthesia . Receives: Drug: remifentanil; Device: laryngeal mask airway; Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful insertion of i-gel and LMA
Measured: from 5 min after anesthetic induction to 1min after device insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraglottic Airways for General AnesthesiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 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
- NCT02382354
- Sponsor's protocol ID
- AJIRB-MED-CT4-14-417
- Status last verified
- Oct 2015
- First submitted
- 25 Feb 2015
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect-site Concentration of Remifentanil for Insertion of the I-gel and Laryngeal Mask Airway During Propofol Anesthesia
- ClinicalTrials.gov ID
- NCT02382354
- Acronym / sponsor ID
- AJIRB-MED-CT4-14-417
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Mar 2015 (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.
Structural differences of supraglottic airway devices could influence the different compressive forces in the oropharyngeal cavities, and require different depth of anesthesia. The addition of remifentanil during propofol anesthesia facilitates the insertion of laryngeal mask airway (LMA) with minimal adverse hemodynamic disturbances. This study was designed to determine the effect-site concentration of remifentanil in 50% of patients (EC50) and 95% of patients (EC95) for successful i- gel insertion, and compare those for LMA insertion during propofol target-controlled infusion (TCI).
Detailed description
Anesthesia was induced with propofol TCI at the effect-site concentration of 5 μg/ml, and the predetermined effect-site concentration of remifentanil was started simultaneously. The remifentanil concentration was determined using modified Dixon's up-and-down method (initial concentration: 3.0 ng/ml, step size: 0.5 ng/ml). Five minutes later, i- gel or LMA insertion was attempted. The response of the patients to the insertion of LMA was classified as either 'movement' or 'no movement'.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i-gel | Experimental | Drug: remifentanil, Device: i-gel, Drug: propofolI-gel insertion was attempted during propofol and remifentanil anesthesia . |
| laryngeal mask airway | Active comparator | Drug: remifentanil, Device: laryngeal mask airway, Drug: propofolLMA insertion was attempted during propofol and remifentanil anesthesia . |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I-II patients undergoing general anesthesia for short elective surgery (<2 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 predetermined effect-site concentration of remifentanil was started using modified Dixon's up-and-down method | Drug | i-gel, laryngeal mask airway |
| i-gelI-gel insertion was inserted 5 min after anesthesia induction | Device | i-gel |
| laryngeal mask airwaylaryngeal mask airway insertion was inserted 5 min after anesthesia induction | Device | laryngeal mask airway |
| propofolAlso: fresofolAnesthesia was induced with propofol target-controlled infusion at the effect-site concentration of 5 μg/ml | Drug | i-gel, laryngeal mask airway |
Primary outcome
successful insertion of i-gel and LMA
Time frame: from 5 min after anesthetic induction to 1min after device insertion
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 Oct 2015.
Related trials for Supraglottic Airways for General Anesthesia
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruiting
SafeLM Versus LMA Classic for Airway Management During Fibroadenoma Excision
Airway Management
Not yet recruiting
Evaluation of SaCo VLMA for General Anesthesia for Laparoscopic Procedures
Laparoscopic Surgical Procedures, Airway Control
Recruiting
The Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients
Airway Management Assessment, Supraglottic Airways
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, i-gel and laryngeal mask airway in people with Supraglottic Airways for General Anesthesia, 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 14 Oct 2015. 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?
successful insertion of i-gel and LMA (time frame: from 5 min after anesthetic induction to 1min after device insertion). 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 14 Oct 2015.