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

NCT ID: NCT01876836

Last Updated: 2013-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-09-30

Brief Summary

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1. i-gel
2. C-LMA

Compare the effect on gastroeosephageal reflux Postoperative complicatios.

Detailed Description

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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.

Conditions

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Bladder Tumour Prostate Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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i-gel

i-gel placed after induction

Group Type EXPERIMENTAL

i-gel

Intervention Type DEVICE

i-gel placed after induction

C-LMA

C-LMA placed after induction

Group Type ACTIVE_COMPARATOR

C-LMA

Intervention Type DEVICE

placed after induction

Interventions

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i-gel

i-gel placed after induction

Intervention Type DEVICE

C-LMA

placed after induction

Intervention Type DEVICE

Other Intervention Names

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supraglottic airway device supraglottic airway device

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Emergency surgery
* Hiatal hernia
* Gastroeosephageal reflux disease
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Reyhan Polat

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reyhan Polat, MD

Role: PRINCIPAL_INVESTIGATOR

Diskapi Yildirim Beyazit Education and Research Hospital

Locations

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DiskapiYBERH

Ankara, Altındağ, Turkey (Türkiye)

Site Status

DiskapiYBERH

Ankara, Altındağ, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Reyhan Polat, MD

Role: CONTACT

+905326734310

Facility Contacts

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Murat Alper, Prof.

Role: primary

+903125962000

Reyhan Polat, MD

Role: primary

+905326734310

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