General AnesthesiaNCT02745964
A Comparison of LMA-Supreme and I-gel for the Incidence of Postoperative Sore Throat
A study testing LMA supreme and I-gel in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate and compare the incidence of the postoperative sore throat between LMA supreme and I-gel. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- General Anesthesia
- What is being tested?
- LMA supreme and I-gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 May 2016to 11 Jun 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients aged over 19 years who are scheduled for elective surgery under general anesthesia using the laryngeal mask airway
Who cannot join
- Anticipated difficult airway
- Expected duration of surgery more than 4 hours
- body mass index more than 35 kg/m2
- pregnancy
- Upper gastrointestinal surgery or open abdominal surgery.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain MedicineSeverance Hospital, Yonsei University Health System
Seoul, Korea, 03722
About this study
The purpose of this study is to investigate and compare the incidence of the postoperative sore throat between LMA supreme and I-gel.
- Conditions
- General Anesthesia
- Being tested
- LMA supreme, I-gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA supremeDevice
Anesthesia is maintained using LMA supreme in LMA supreme group or using I-gel in I-gel group according to the randomly allocated groups.
I-gelDevice
Anesthesia is maintained using LMA supreme in LMA supreme group or using I-gel in I-gel group according to the randomly allocated groups.
| Study group | Role | What they receive |
|---|---|---|
| LMA supreme | Experimental | Anesthesia is maintained using LMA supreme during surgery. Receives: Device: LMA supreme |
| I-gel | Active comparator | Anesthesia is maintained using I-gel during surgery. Receives: Device: I-gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative sore throat
The postoperative sore throat will be evaluated after the end of surgery by the investigator who are blinded to the group assignments. The investigator will ask the participant about his/her sore throat status.
Measured: within 24 hours after the end of surgery.
Secondary outcomes (2)
Postoperative dysphagia
The postoperative dysphagia will be evaluated after the end of surgery by the investigator who are blinded to the group assignments. The investigator will ask the participant about his/her status.
Measured: within 24 hours after the end of surgery
Postoperative dysphonia
The postoperative dysphonia will be evaluated after the end of surgery by the investigator who are blinded to the group assignments. The investigator will ask the participant about his/her status.
Measured: within 24 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study start9 May 2016
- Primary completion11 Jun 2016
- Study completion11 Jun 2016
Why it stopped: This study was closed earlier than planned because of lack of research staff.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 8 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
- NCT02745964
- Sponsor's protocol ID
- 4-2016-0144
- Status last verified
- Jul 2018
- First submitted
- 18 Apr 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of LMA-Supreme and I-gel for the Incidence of Postoperative Sore Throat
- ClinicalTrials.gov ID
- NCT02745964
- Acronym / sponsor ID
- 4-2016-0144
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was closed earlier than planned because of lack of research staff.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 9 May 2016 (actual)
- Primary completion
- 11 Jun 2016 (actual)
- Study completion
- 11 Jun 2016 (actual)
- First posted
- 20 Apr 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.
The purpose of this study is to investigate and compare the incidence of the postoperative sore throat between LMA supreme and I-gel.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA supreme | Experimental | Device: LMA supremeAnesthesia is maintained using LMA supreme during surgery. |
| I-gel | Active comparator | Device: I-gelAnesthesia is maintained using I-gel during surgery. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients aged over 19 years who are scheduled for elective surgery under general anesthesia using the laryngeal mask airway
Key exclusion criteria (5 listed)
- Anticipated difficult airway
- Expected duration of surgery more than 4 hours
- body mass index more than 35 kg/m2
- pregnancy
- Upper gastrointestinal surgery or open abdominal surgery.
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 |
|---|---|---|
| LMA supremeAnesthesia is maintained using LMA supreme in LMA supreme group or using I-gel in I-gel group according to the randomly allocated groups. | Device | LMA supreme |
| I-gelAnesthesia is maintained using LMA supreme in LMA supreme group or using I-gel in I-gel group according to the randomly allocated groups. | Device | I-gel |
Primary outcome
Postoperative sore throat
Time frame: within 24 hours after the end of surgery.
The postoperative sore throat will be evaluated after the end of surgery by the investigator who are blinded to the group assignments. The investigator will ask the participant about his/her sore throat status.
2 secondary outcomes
Postoperative dysphagia
Time frame: within 24 hours after the end of surgery
Postoperative dysphonia
Time frame: within 24 hours after the end of surgery
Results and safety
The study was stopped early (reason given: This study was closed earlier than planned because of lack of research staff.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Individual participant dataSharing planned: No. no plan to share data
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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 LMA supreme and I-gel in people with General Anesthesia, 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 1 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: stopped early, as of the sponsor's last update on 18 Jul 2018. 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 was stopped early (reason given: This study was closed earlier than planned because of lack of research staff.). Results are not available in the source record.
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?
Postoperative sore throat (time frame: within 24 hours after the end of surgery.). 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 18 Jul 2018.