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
- i-gel
- 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
- i-gel
- 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 Locations
-
-
Altındağ
-
Ankara, Altındağ, Turkey, 06610
- DiskapiYBERH
-
-
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
|
i-gel placed after induction
Other Names:
|
|
Active Comparator: C-LMA
C-LMA placed after induction
|
placed after induction
Other Names:
|
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.
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
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.