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

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

Study Overview

• Status: Terminated
• Conditions: General Anesthesia
• Intervention / Treatment: Device: LMA supreme; Device: I-gel

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LMA supreme; Anesthesia is maintained using LMA supreme during surgery.	Device: LMA 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.
Active Comparator: I-gel; Anesthesia is maintained using I-gel during surgery.	Device: I-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 24 hours after the end of surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	within 24 hours after the end of surgery

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2016
• Primary Completion (Actual): June 11, 2016
• Study Completion (Actual): June 11, 2016

Study Registration Dates

• First Submitted: April 18, 2016
• First Submitted That Met QC Criteria: April 18, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 15, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 4-2016-0144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan to share data