Clinical trial NCT04275531: Neurotoxicity of Anesthesia in Middle Aged Patients
Official title: Evaluation of Possible Neurotoxicity of Anesthesia Guided by Olfactory Changes in Middle-aged Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia; Adverse Effect
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* patients aged 18-50 years
* both sex
* American society of Anesthesiologists' physical status I and II
* elective surgery of duration 90-120 minutes

Exclusion Criteria:

* patients's refusal
* recent airway infection
* allergic rhinitis
* nasal polyps
* history of alcoholism
* smoking
* pregnancy
* menstruating female
* mental retardation
* psychiatric illness
* neurosurgical or oto-rhino-laryngeal surgery
* history of olfactory deficits or cognitive impairment
* CNS disease e.g. epilepsy
* history of first degree relative with alzheimer's disease,dementia, or cognitive dysfunction
* those who are unable to answer the tests themselves

Primary outcomes:
measure: olfactory threshold
timeFrame: olfactory threshold will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative
Secondary outcomes:
measure: olfactory identification
timeFrame: Smell identification will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative
measure: cognitive dysfunction
timeFrame: Cognitive dysfunction will be evaluated at 12 hours preoperative then at 6, 24 and 48 hours postoperative
measure: serum melatonin concentrations
timeFrame: serum melatonin will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University, Faculty of Medicine
Study officials:
affiliation: Tanta University, Faculty of Medicine
name: Mona R Elghamry, MD
role: PRINCIPAL_INVESTIGATOR
References: