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CompletedNCT03100604Updated Apr 11, 2017

The Effect of General Anesthesia on the Middle Ear Pressure

An interventional study of desflurane, and Sevoflurane in Ear Deformities, Acquired, sponsored by Trakya University. Completed. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-04-11.

Sponsored by Trakya University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ear Deformities, Acquired

Keywords

  • middle ear pressure
  • sevoflurane
  • desflurane
03

In context

Lead sponsor

Trakya University is the lead sponsor of 150 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • (ASA) II-III physical status
  • elective inguinal hernia
  • lower extremity surgery
  • general anesthesia
  • supine position

Exclusion criteria

Exclusion Criteria:

  • nasal septum,
  • adenotonsillar hypertrophy,
  • perforated tympanic membrane,
  • middle ear pathology
  • receive medications for middle ear pressure .
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    sevoflurane 2%, 1 MAC

    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

  • Experimental
    Desfluran 6-9% 1MAC

    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,

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).

    Also known as: suprane

  • DrugSevoflurane

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

    Also known as: sefoflurane

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: postoperative 30th minutes

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03100604
Lead sponsor
Trakya University
Responsible party
Sevtap Hekimoglu Sahin (Clinical Professor, Trakya University) — Principal investigator
First posted
Apr 4, 2017
Start date
Aug 2013
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Apr 11, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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