The Effect of General Anesthesia on the Middle Ear Pressure

Ear Deformities, Acquired Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100604
• Other study ID #: 2013/136
• Status: Completed
• Phase: N/A
• First received: August 31, 2016
• Last updated: April 7, 2017
• Start date: August 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2017
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Ear Deformities, Acquired

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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