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

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.

Study Overview

• Status: Completed
• Conditions: Airway Complication of Anaesthesia
• Intervention / Treatment: Device: PROSEAL LMA; Device: SUPREMA LMA; Device: I-GEL LMA

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey, 44100
    • İnonu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 18- 60 YEARS

Exclusion Criteria:

• ASA 3-4 patients
• BMI 40

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ProSeal LMA; Supraglottic airway device	Device: PROSEAL LMA; Size 3,4 or 5 supraglottic device with orogastric drainage tube
Active Comparator: suprema LMA; Supraglottic airway device	Device: SUPREMA LMA; Size 3,4 or 5, disposable supraglottic device with orogastric drainage tube
Active Comparator: I-gel LMA; Supraglottic airway device	Device: I-GEL LMA; Size 3,4,5 disposable supraglottic device with noninflatable cuff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of oropharyngeal leak pressure	During intraoperative period, oropharyngeal leak pressure was measured at three times (10min, 30 min, and 45 min after insertion of devices)	10min, 30 min ,45 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
easiness of insertion of the device	During insertion, easiness of the devices were evaluated by a scale	2 min

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complication	At the second hour of postoperative period, patients will visit and will examine about the complications (sore throat, dysphagia, dysphonia)	2 hour after operation

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Principal Investigator: mukadder sanli, MD, Assistant Prof Dr

Publications and helpful links

General Publications

• Singh I, Gupta M, Tandon M. Comparison of Clinical Performance of I-Gel with LMA-Proseal in Elective Surgeries. Indian J Anaesth. 2009 Jun;53(3):302-5.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: June 21, 2013
• First Submitted That Met QC Criteria: July 25, 2013
• First Posted (Estimate): July 26, 2013

Study Record Updates

• Last Update Posted (Estimate): July 26, 2013
• Last Update Submitted That Met QC Criteria: July 25, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: airway management
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis
• Other Study ID Numbers: 2011/188