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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sevoflurane 2%, 1 MAC | Experimental | 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. |
|
| Desfluran 6-9% 1MAC | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| desflurane, | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 4, 2017 | |
| Reset | Jun 8, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 4, 2017 | Jun 8, 2017 |
| ID | Term |
|---|---|
| D004426 | Ear Deformities, Acquired |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000077335 | Desflurane |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
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|
| Sevoflurane | Drug | For a drug, use generic name if established. Use the same name as in the associated Arm/Group Description(s). |
|
|
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |