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TerminatedNCT02745964Updated Jul 18, 2018

A Comparison of LMA-Supreme and I-gel for the Incidence of Postoperative Sore Throat

An interventional study of LMA supreme and I-gel in General Anesthesia, sponsored by Yonsei University. Terminated at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2018-07-18.

Sponsored by Yonsei University · Not applicable, Interventional, and Prevention

Why this study was terminated
This study was closed earlier than planned because of lack of research staff.
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

The purpose of this study is to investigate and compare the incidence of the postoperative sore throat between LMA supreme and I-gel.

02

Conditions studied

  • General Anesthesia
03

In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • adult patients aged over 19 years who are scheduled for elective surgery under general anesthesia using the laryngeal mask airway

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    LMA supreme

    Anesthesia is maintained using LMA supreme during surgery.

    Device: LMA supreme

  • Active comparator
    I-gel

    Anesthesia is maintained using I-gel during surgery.

    Device: I-gel

Interventions

  • DeviceLMA supreme

    Anesthesia is maintained using LMA supreme in LMA supreme group or using I-gel in I-gel group according to the randomly allocated groups.

  • DeviceI-gel

    Anesthesia is maintained using LMA supreme in LMA supreme group or using I-gel in I-gel group according to the randomly allocated groups.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: within 24 hours after the end of surgery.

Secondary outcomes

  1. 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.

    Time frame: within 24 hours after the end of surgery

  2. 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.

    Time frame: within 24 hours after the end of surgery

07

Study locations

1 site
  • Department of Anesthesiology and Pain MedicineSeverance Hospital, Yonsei University Health System
    Seoul, Korea 03722, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No — no plan to share data

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02745964
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Apr 20, 2016
Start date
May 9, 2016
Primary completion
Jun 11, 2016
Completion
Jun 11, 2016
Last update
Jul 18, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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