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NCT01876836 Clinical Trial

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

Prostate Hyperplasia Clinical Trial

— C-LMA  

Official title:
Comparation the Effect of C-LMA and I-gel in Regurgitation and Postoperative Complications

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01876836
Other study ID #
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received June 10, 2013
Last updated June 11, 2013
Start date July 2013
Est. completion date September 2013

Study information
Verified date June 2013
Source Diskapi Yildirim Beyazit Education and Research Hospital
Contact Reyhan Polat, MD
Phone +905326734310
Email reyhanp9@gmail.com
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial Summary

1. i-gel

2. C-LMA

Compare the effect on gastroeosephageal reflux Postoperative complicatios.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date September 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 70 Years
Eligibility Inclusion Criteria:

- ASA I-II

- Adult

- Elective surgery

- Bladder tumour

- Prostat hyperplasi

Exclusion Criteria:

- Emergency surgery

- Hiatal hernia

- Gastroeosephageal reflux disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Intervention

Device:
• i-gel
i-gel placed after induction
• C-LMA
placed after induction

Locations
Country Name City State
Turkey DiskapiYBERH Ankara Altindag
Turkey DiskapiYBERH Ankara Altindag

Sponsors (1)
Lead Sponsor Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Other Blue dye on airway device the airway device will be examined for a precence of blue dye 1 min after extubation Yes
Primary Ph MEASUREMENT The ph of the secretions on the airway device will be measurd with a Ph-meter 1 MINUTE AFTER EXTUBATION Yes
Secondary Bleu dye on the airway device The airway device will be examined with fiberoptic endoscope after placement 5 min after placenent Yes
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