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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor:
Information provided by (Responsible Party):
Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT01876836
First received: June 10, 2013
Last updated: June 11, 2013
Last verified: June 2013
  Purpose
  1. i-gel
  2. C-LMA

Compare the effect on gastroeosephageal reflux Postoperative complicatios.


Condition Intervention Phase
Bladder Tumour
Prostate Hyperplasia
Device: i-gel
Device: C-LMA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Comparation the Effect of C-LMA and I-gel in Regurgitation and Postoperative Complications

Resource links provided by NLM:


Further study details as provided by Diskapi Yildirim Beyazit Education and Research Hospital:

Primary Outcome Measures:
  • Ph MEASUREMENT [ Time Frame: 1 MİNUTE AFTER EXTUBATİON ] [ Designated as safety issue: Yes ]
    The ph of the secretions on the airway device will be measurd with a Ph-meter


Secondary Outcome Measures:
  • Bleu dye on the airway device [ Time Frame: 5 min after placenent ] [ Designated as safety issue: Yes ]
    The airway device will be examined with fiberoptic endoscope after placement


Other Outcome Measures:
  • Blue dye on airway device [ Time Frame: 1 min after extubation ] [ Designated as safety issue: Yes ]
    the airway device will be examined for a precence of blue dye


Estimated Enrollment: 120
Study Start Date: July 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: i-gel
i-gel placed after induction
Device: i-gel
i-gel placed after induction
Other Name: supraglottic airway device
Active Comparator: C-LMA
C-LMA placed after induction
Device: C-LMA
placed after induction
Other Name: supraglottic airway device

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.
  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Emergency surgery
  • Hiatal hernia
  • Gastroeosephageal reflux disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876836

Contacts
Contact: Reyhan Polat, MD +905326734310 reyhanp9@gmail.com

Locations
Turkey
DiskapiYBERH Not yet recruiting
Ankara, Altındağ, Turkey, 06610
Contact: Murat Alper, Prof.    +903125962000    muratalper@hotmail.com   
Principal Investigator: Reyhan Polat, MD         
DiskapiYBERH Not yet recruiting
Ankara, Altındağ, Turkey, 06610
Contact: Reyhan Polat, MD    +905326734310    reyhanp9@gmail.com   
Principal Investigator: Reyhan Polat, MD         
Sponsors and Collaborators
Diskapi Yildirim Beyazit Education and Research Hospital
Investigators
Principal Investigator: Reyhan Polat, MD Diskapi Yildirim Beyazit Education and Research Hospital
  More Information

No publications provided

Responsible Party: Reyhan Polat, Doctor, Diskapi Yildirim Beyazit Education and Research Hospital
ClinicalTrials.gov Identifier: NCT01876836     History of Changes
Other Study ID Numbers: No
Study First Received: June 10, 2013
Last Updated: June 11, 2013
Health Authority: Turkey: Ministry of Health

Keywords provided by Diskapi Yildirim Beyazit Education and Research Hospital:
i-gel
C-LMA
gastroeosephageal reflux
sore troat

Additional relevant MeSH terms:
Hyperplasia
Postoperative Complications
Prostatic Hyperplasia
Urinary Bladder Neoplasms
Genital Diseases, Male
Neoplasms
Neoplasms by Site
Pathologic Processes
Prostatic Diseases
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 30, 2014