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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02745964
Other study ID # 4-2016-0144
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 9, 2016
Est. completion date June 11, 2016

Study information

Verified date July 2018
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date June 11, 2016
Est. primary completion date June 11, 2016
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Korea, Republic of Department of Anesthesiology and Pain MedicineSeverance Hospital, Yonsei University Health System Seoul Korea

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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