The Effects of Different Airway Devices on Middle Ear Pressure in Pediatric Patients

Not Applicable

• Conditions: Local Pressure Effects; Simple Ear

• Registration Number: NCT02334072
• Lead Sponsor: Adiyaman University Research Hospital

Brief Summary

Even though the effects of anesthetic agents both inhalation and intravenous have been well described, the effect of laryngeal mask airways haven't. The purpose of the study is to determine the effects of different types of laryngeal mask airways on middle ear pressure.

Detailed Description

All the patients in each group of laryngeal mask airway will contain 20 patients. In all groups middle ear pressures will be measured, in both right and left ear, preoperatively, after induction of anesthesia, insertion of laryngeal mask and in 1st., 5th., 10th. minutes and every 5 minutes perioperatively and recorded. Also the heart rates,arterial oxygen saturation (SaO2), airway pressures and end-tidal carbon dioxide values will be recorded before and following induction of anesthesia and in 1st., 5th., 10th. minutes and every five minutes perioperatively. Patients will be followed during the hospital stay for any complications.In all groups premedication will be done with midazolam. Anesthesia will be inducted with propofol and fentanyl; and maintained with sevoflurane-air combination.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-05
• Study First Submitted QC: 2015-01-07
• Study First Posted: 2015-01-08
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-22
• Last Update Posted: 2015-06-23
• Primary Completion: 2015-08
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Elective patients undergoing subumbilical surgery under general anesthesia

Exclusion Criteria

• Emergency conditions
• Rejection of patient approval
• Tympanic membrane perforation history
• Anticipated difficult airway
• Contraindications for LMA application

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Middle ear pressure changes after the device application (MEP)	Perioperative

Secondary Outcome Measures

Name	Time	Method
Composite Hemodynamics	Perioperative	Heart rate,arterial blood pressure, haemoglobin saturation rate

Trial Locations

Locations (1)

Adiyaman University Research Hospital; 🇹🇷 Adiyaman, Turkey