Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01909297
Enrollment
35
Registered
2013-07-26
Start date
2013-05-31
Completion date
2013-07-31
Last updated
2013-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Complication of Anaesthesia

Keywords

airway management

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).

Interventions

Size 3,4 or 5 supraglottic device with orogastric drainage tube

DEVICESUPREMA LMA

Size 3,4 or 5, disposable supraglottic device with orogastric drainage tube

DEVICEI-GEL LMA

Size 3,4,5 disposable supraglottic device with noninflatable cuff

Sponsors

Inonu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* 18- 60 YEARS

Exclusion criteria

* ASA 3-4 patients * BMI 40

Design outcomes

Primary

MeasureTime frameDescription
change of oropharyngeal leak pressure10min, 30 min ,45 minDuring intraoperative period, oropharyngeal leak pressure was measured at three times (10min, 30 min, and 45 min after insertion of devices)

Secondary

MeasureTime frameDescription
easiness of insertion of the device2 minDuring insertion, easiness of the devices were evaluated by a scale

Other

MeasureTime frameDescription
postoperative complication2 hour after operationAt the second hour of postoperative period, patients will visit and will examine about the complications (sore throat, dysphagia, dysphonia)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026