Back to resultsThe Effect of General Anesthesia on the Middle Ear Pressure
Primary Purpose
Ear Deformities, Acquired
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
desflurane,
Sevoflurane
Sponsored by
About this trial
This is an interventional treatment trial for Ear Deformities, Acquired focused on measuring middle ear pressure, sevoflurane, desflurane
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 .
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
sevoflurane 2%, 1 MAC
Desfluran 6-9% 1MAC
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03100604
Brief Title
The Effect of General Anesthesia on the Middle Ear Pressure
Official Title
Prospective, Single-blind Study Investigating the Effect of Sevoflurane and Desflurane, Agents Used in Patients on the MEP
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trakya University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ear Deformities, Acquired
Keywords
middle ear pressure, sevoflurane, desflurane
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sevoflurane 2%, 1 MAC
Arm Type
Experimental
Arm Description
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.
Arm Title
Desfluran 6-9% 1MAC
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
desflurane,
Other Intervention Name(s)
suprane
Intervention Description
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
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
sefoflurane
Intervention Description
For a drug, use generic name if established. Use the same name as in the associated Arm/Group Description(s).
Primary Outcome Measure Information:
Title
Middle ear pressure
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 .
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of General Anesthesia on the Middle Ear Pressure
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