Clasic Laryngeal Mask Airway(C-LMA) and I-gel Releated Regurgitation and Complications

Phase 4

• Conditions: Bladder Tumour; Prostate Hyperplasia
• Interventions: Device: i-gel; Device: C-LMA

• Registration Number: NCT01876836
• Lead Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

Brief Summary

1. i-gel

2. C-LMA

Compare the effect on gastroeosephageal reflux Postoperative complicatios.

Detailed Description

120 ASA I-II adult patients. Patients were randomised into two groups

1. i-gel

2. C-LMA Volume controlled ventilation, general anesthesia Asses Gastroeosephageal reflux, sore throat, coughing, dysphagia,dysphonia recorded.

Study Timeline

• Status Verified: 2013-06
• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-11
• Last Update Submitted: 2013-06-11
• Study First Posted: 2013-06-13
• Last Update Posted: 2013-06-13
• Study Start: 2013-07
• Primary Completion: 2013-08
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• ASA I-II
• Adult
• Elective surgery
• Bladder tumour
• Prostat hyperplasi

Exclusion Criteria

• Emergency surgery
• Hiatal hernia
• Gastroeosephageal reflux disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
i-gel	i-gel	i-gel placed after induction
C-LMA	C-LMA	C-LMA placed after induction

Primary Outcome Measures

Name	Time	Method
Ph MEASUREMENT	1 MİNUTE AFTER EXTUBATİON	The ph of the secretions on the airway device will be measurd with a Ph-meter

Secondary Outcome Measures

Name	Time	Method
Bleu dye on the airway device	5 min after placenent	The airway device will be examined with fiberoptic endoscope after placement

Trial Locations

Locations (1)

DiskapiYBERH; 🇹🇷 Ankara, Altındağ, Turkey