The Effect of General Anesthesia on the Middle Ear Pressure

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.

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Key information

Conditions

Ear Deformities, Acquired Ear Diseases Otorhinolaryngologic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

desflurane,

Drug

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).

Other names: suprane

Sevoflurane

Drug

For a drug, use generic name if established. Use the same name as in the associated Arm/Group Description(s).

Other names: sefoflurane

Primary outcomes

Middle ear pressure

Time frame: postoperative 30th minutes

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

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Apr 4, 2017
Registry last updated: Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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