The Effect of General Anesthesia on the Middle Ear Pressure

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to examine the effect of sevoflurane and desflurane, agents used in patients who do not have any ear pathology and undergo surgery under general anesthesia, on the MEP.

Detailed Description
-----------------
Studies reported that inhalation agents are more likely to have impacts on the middle ear pressure compared to intravenous anesthetic agents. Despite numerous studies comparing the effects of inhalation agents on the middle ear pressure, this is the first clinical trial in which end tidal carbon dioxide and effects of sevoflurane and desflurane, along with other anesthetic analgesic agents used, on the middle ear pressure were compared. Our purpose in this study was to investigate the effect of sevoflurane and desflurane, inhalation agents used in patients who do not have any ear pathology and undergo non-ear surgery under general anesthesia, on the middle ear pressure.

Official Title
-----------------
Prospective, Single-blind Study Investigating the Effect of Sevoflurane and Desflurane, Agents Used in Patients on the MEP

Conditions
-----------------
Ear Deformities, Acquired

Intervention / Treatment
-----------------
* Drug: desflurane,
* Drug: Sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (ASA) II-III physical status elective inguinal hernia lower extremity surgery general anesthesia supine position Exclusion Criteria: nasal septum, adenotonsillar hypertrophy, perforated tympanic membrane, middle ear pathology receive medications for middle ear pressure .

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sevoflurane 2%, 1 MAC<br>Maintenance of anesthesia was provided with 2% sevoflurane in S Group, and 6-9% desflurane in D Group, with 50% air /oxygen mixture and fresh gas flow at 4 l/min in both groups. | Drug: Sevoflurane<br>* For a drug, use generic name if established. Use the same name as in the associated Arm/Group Description(s).<br>* Other names: sefoflurane;|
| Experimental: Desfluran 6-9% 1MAC<br>Maintenance of anesthesia was provided with 2% sevoflurane in S Group, and 6-9% desflurane in D Group, with 50% air /oxygen mixture and fresh gas flow at 4 l/min in both groups. | Drug: desflurane,<br>* Patients were divided into two groups according to inhalation agent administered for the surgery; Sevofluran, Group S (n=25) and Desfluran, Group D (N=25).<br>* Other names: suprane;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Middle ear pressure | Tympanometric measurements were performed and recorded for each ear preoperatively, at intraoperative 5th, 10th and 15th minutes and postoperative 10th and 30th minutes. Normal middle ear pressure ranges between -200 and +200 decapascals (daPa). Treatment-Related Adverse Events, Ear and labyrinth disorder Assessed by CTCAE v4.0 | postoperative 30th minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
middle ear pressure, sevoflurane, desflurane