The Effect of General Anesthesia on the Middle Ear Pressure
Prospective, Single-blind Study Investigating the Effect of Sevoflurane and Desflurane, Agents Used in Patients on the MEP
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2013
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 31, 2016
CompletedFirst Posted
Study publicly available on registry
April 4, 2017
CompletedApril 11, 2017
April 1, 2017
2.6 years
August 31, 2016
April 7, 2017
Conditions
Keywords
Outcome Measures
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
postoperative 30th minutes
Study Arms (2)
sevoflurane 2%, 1 MAC
EXPERIMENTALMaintenance 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.
Desfluran 6-9% 1MAC
EXPERIMENTALMaintenance 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.
Interventions
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).
For a drug, use generic name if established. Use the same name as in the associated Arm/Group Description(s).
Eligibility Criteria
You may qualify if:
- (ASA) II-III physical status
- elective inguinal hernia
- lower extremity surgery
- general anesthesia
- supine position
You may not qualify if:
- nasal septum,
- adenotonsillar hypertrophy,
- perforated tympanic membrane,
- middle ear pathology
- receive medications for middle ear pressure .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
August 31, 2016
First Posted
April 4, 2017
Study Start
August 1, 2013
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
April 11, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share