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Clinical Trials/NCT01909297
NCT01909297
Completed
Not Applicable

Comparison of the I-gel, Supreme and Proseal LMA in Paralyzed Patients Undergoing Gynaecological Laparoscopic Surgery With Oropharyngeal Leak Pressure

Inonu University1 site in 1 country35 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Airway Complication of Anaesthesia
Sponsor
Inonu University
Enrollment
35
Locations
1
Primary Endpoint
change of oropharyngeal leak pressure
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The investigators aimed to compare of the i-gel, supreme and proseal laryngeal mask airways in paralysed patients undergoing gynaecological laparoscopic surgery with oropharyngeal leak pressure. The investigators also studied their relative ease of insertion, time to insertion and complications of use as secondary outcome measures.

Detailed Description

A total of 105 patients scheduled for elective gynaecological laparoscopic procedures in our Inonu University Medical Faculty Hospital were recruited.They were equally randomized into three groups: PLMA, supreme and i-gel groups. All three devices were compared with regard to oropharyngeal leak pressure, number and duration of insertion attempts and complications of airway. Oropharyngeal leak pressure will evaluate including to start,trendelenburg and postoperative at period. Fiberoptic evaluation of the LMA's position were performed after successful insertion and determination of the airway pressures. After one hour patients were evaluated by a blinded independent observer for postoperative complications ( sore throat, dysphonia and dysphagia).

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
July 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mukadder Sanli

assistant professor

Inonu University

Eligibility Criteria

Inclusion Criteria

  • 18- 60 YEARS

Exclusion Criteria

  • ASA 3-4 patients

Outcomes

Primary Outcomes

change of oropharyngeal leak pressure

Time Frame: 10min, 30 min ,45 min

During intraoperative period, oropharyngeal leak pressure was measured at three times (10min, 30 min, and 45 min after insertion of devices)

Secondary Outcomes

  • easiness of insertion of the device(2 min)

Study Sites (1)

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