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

June 11, 2013 updated by: Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital

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

  1. i-gel
  2. C-LMA

Compare the effect on gastroeosephageal reflux Postoperative complicatios.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Altındağ
      • Ankara, Altındağ, Turkey, 06610
        • DiskapiYBERH
        • Contact:
        • Principal Investigator:
          • Reyhan Polat, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Emergency surgery
  • Hiatal hernia
  • Gastroeosephageal reflux disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: i-gel
i-gel placed after induction
Device: i-gel
i-gel placed after induction
Other Names:
  • supraglottic airway device
Active Comparator: C-LMA
C-LMA placed after induction
Device: C-LMA
placed after induction
Other Names:
  • supraglottic airway device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ph MEASUREMENT
Time Frame: 1 MİNUTE AFTER EXTUBATİON
The ph of the secretions on the airway device will be measurd with a Ph-meter
1 MİNUTE AFTER EXTUBATİON

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleu dye on the airway device
Time Frame: 5 min after placenent
The airway device will be examined with fiberoptic endoscope after placement
5 min after placenent

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blue dye on airway device
Time Frame: 1 min after extubation
the airway device will be examined for a precence of blue dye
1 min after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Investigators

  • Principal Investigator: Reyhan Polat, MD, Diskapi Yildirim Beyazit Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

June 10, 2013

First Submitted That Met QC Criteria

June 11, 2013

First Posted (Estimate)

June 13, 2013

Study Record Updates

Last Update Posted (Estimate)

June 13, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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