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

NCT02745964 | Terminated

• 1 other identifier: 4-2016-0144
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

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.

  within 24 hours after the end of surgery.

Secondary Outcomes (2)

• Postoperative dysphagia

  within 24 hours after the end of surgery

• Postoperative dysphonia

  within 24 hours after the end of surgery

Study Arms (2)

LMA supreme

EXPERIMENTAL

Anesthesia is maintained using LMA supreme during surgery.

Device: LMA supreme

I-gel

ACTIVE COMPARATOR

Anesthesia is maintained using I-gel during surgery.

Device: I-gel

Interventions

LMA supreme DEVICE

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

LMA supreme

I-gel DEVICE

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-gel

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain MedicineSeverance Hospital, Yonsei University Health System

Seoul, Korea, 03722, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 20, 2016
• Study Start: May 9, 2016
• Primary Completion: June 11, 2016
• Study Completion: June 11, 2016
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)