The Effect of General Anesthesia on the Middle Ear Pressure

NCT ID: NCT03100604

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-03-31

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.

Conditions

Ear Deformities, Acquired

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sevoflurane

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

desflurane,

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

Sevoflurane

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

Intervention Type: DRUG

Other Intervention Names

suprane; sefoflurane

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 .

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trakya University

OTHER

Sponsor Role: lead

Responsible Party

Sevtap Hekimoglu Sahin

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2013/136

Identifier Type: -

Identifier Source: org_study_id