Clinical Trials Directory

Trials / Completed

CompletedNCT01909297

Comparison of the I-gel, Supreme and Proseal LMA in Paralyzed Patients

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Inonu University · Academic / Other
Sex
Female
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DEVICEPROSEAL LMASize 3,4 or 5 supraglottic device with orogastric drainage tube
DEVICESUPREMA LMASize 3,4 or 5, disposable supraglottic device with orogastric drainage tube
DEVICEI-GEL LMASize 3,4,5 disposable supraglottic device with noninflatable cuff

Timeline

Start date
2013-05-01
Primary completion
2013-06-01
Completion
2013-07-01
First posted
2013-07-26
Last updated
2013-07-26

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT01909297. Inclusion in this directory is not an endorsement.