The Effect of General Anesthesia on the Middle Ear Pressure

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03100604

Enrollment

Registered

2017-04-04

Start date

2013-08-31

Completion date

2016-03-31

Last updated

2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ear Deformities, Acquired

Keywords

middle ear pressure, sevoflurane, desflurane

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.

Interventions

DRUGdesflurane,

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).

DRUGSevoflurane

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

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 .

Design outcomes

Primary

Measure	Time frame	Description
Middle ear pressure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026