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

Not Applicable

Completed

• Conditions: Airway Complication of Anaesthesia
• Interventions: Device: PROSEAL LMA; Device: SUPREMA LMA; Device: I-GEL LMA

• Registration Number: NCT01909297
• Lead Sponsor: Inonu University

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).

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2013-06
• Study First Submitted: 2013-06-21
• Status Verified: 2013-07
• Study Completion: 2013-07
• Study First Submitted QC: 2013-07-25
• Last Update Submitted: 2013-07-25
• Study First Posted: 2013-07-26
• Last Update Posted: 2013-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

• 18- 60 YEARS

Exclusion Criteria

• ASA 3-4 patients
• BMI 40

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ProSeal LMA	PROSEAL LMA	Supraglottic airway device
suprema LMA	SUPREMA LMA	Supraglottic airway device
I-gel LMA	I-GEL LMA	Supraglottic airway device

Primary Outcome Measures

Name	Time	Method
change of oropharyngeal leak pressure	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 Outcome Measures

Name	Time	Method
easiness of insertion of the device	2 min	During insertion, easiness of the devices were evaluated by a scale

Trial Locations

Locations (1)

Inonu University; 🇹🇷 Malatya, Turkey