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for the last 20 years, the increasing reports from non-human studies have raised suspicion that general anesthetics may cause neurotoxic changes in the developing brain that lead to adverse neurodevelopmental outcomes later in life.there are several case reports of reversible smell and taste dysfunction following exposure to general anesthesia suggesting a possible relationship between anesthetic agents and olfactory dysfunction.
this study is to assess the possible neurotoxicity of sevoflurane,isoflurane,and propofol based anesthesia guided by olfactory changes
the primary inhibitory neurotransmitter GABA is found in neuronal synapses involving olfactory bulb. So, the involvement of common GABA pathway implies a possible interaction of general anesthetics with olfactory function.
olfactory identification is an associative memory which is found to be facilitated by action of melatonin. involvement of GABA receptor in the transfer of light information from suprachiasmatic nuclei to pineal gland suggests possible interaction of melatonin and anesthetic agents.
the aim of the study is to evaluate the possible neurotoxicity of sevoflurane,isoflurane,and propofol based anesthesia guided by olfactory changes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| regional anesthesia | surgical procedures which will be performed under intrathecal anesthesia without sedation |
| |
| sevoflurane | surgical procedures which will be performed under general anesthesia and sevoflurane will be used for maintenance of anesthesia |
| |
| isoflurane | surgical procedures which will be performed under general anesthesia and isoflurane will be used for maintenance of anesthesia |
| |
| propofol | surgical procedures which will be performed under general anesthesia and propofol infusion will be used for maintenance of anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anesthesia Agent | Drug | various anesthetic agents used in both general and regional anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| olfactory threshold | we will use (10 dilutions) of 4% n-butyl alcohol. The odorant and a blank will be presented to the participant. The test will be progressed from weaker-to-stronger concentrations of odorant. Two bottles will be presented to each participant, an odorant bottle and an identical bottle filled with distilled water. The participant will sniff each one for 9 seconds and then will chose which one smelled stronger. If the participant is incorrect at one concentration, the next higher concentration will be presented. When the correct choice is made, the same concentration of odorant will be presented to the participant until four consecutive correct responses are given. | olfactory threshold will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| olfactory identification | We will use UPSIT test. | Smell identification will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative |
| cognitive dysfunction | cognitive dysfunction will be evaluated by mini-mental state examination |
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Inclusion Criteria:
Exclusion Criteria:
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middle aged patients, of both sex, undergoing elective surgical procedures other than major surgeries, of duration 90-120 minutes, and of American Society of Anesthesiologists' physical status I and II will be enrolled in the study
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| Name | Affiliation | Role |
|---|---|---|
| Mona R Elghamry, MD | Tanta University, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University, Faculty of Medicine | Tanta | 31527 | Egypt |
statistics of demographic data,type of surgeries, olfactory dysfunction tests,mini-mental state examination, and serum melatonin
Individual patient data will be shared after finishing and publication of the study and it will be available for 6 months.
the individual patient data will be available for scientific research only up on email request. request will be sent to email of principal investigator (drmonagh19802000@gmail.com)
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| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D000077149 | Sevoflurane |
| D007530 | Isoflurane |
| ID | Term |
|---|---|
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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|
| Cognitive dysfunction will be evaluated at 12 hours preoperative then at 6, 24 and 48 hours postoperative |
| serum melatonin concentrations | Melatonin levels will be measured in plasma by the enzyme-linked immunosorbent assay (ELISA) | serum melatonin will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |