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
| Type | Name | Description |
|---|---|---|
| DEVICE | PROSEAL LMA | Size 3,4 or 5 supraglottic device with orogastric drainage tube |
| DEVICE | SUPREMA LMA | Size 3,4 or 5, disposable supraglottic device with orogastric drainage tube |
| DEVICE | I-GEL LMA | Size 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.