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Clinical Trials/NCT03100604
NCT03100604
Completed
Not Applicable

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

Trakya University0 sites50 target enrollmentAugust 2013

Overview

Phase
Not Applicable
Intervention
Sevoflurane
Conditions
Ear Deformities, Acquired
Sponsor
Trakya University
Enrollment
50
Primary Endpoint
Middle ear pressure
Status
Completed
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
March 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sevtap Hekimoglu Sahin

Clinical Professor

Trakya University

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 .

Arms & Interventions

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.

Intervention: Sevoflurane

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.

Intervention: desflurane,

Outcomes

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

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