Neurotoxicity of Anesthesia in Middle Aged Patients

Anesthesia; Adverse Effect Clinical Trial

Official title:

Evaluation of Possible Neurotoxicity of Anesthesia Guided by Olfactory Changes in Middle-aged Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04275531
• Other study ID #: neurotoxicity of anesthesia
• Status: Active, not recruiting
• Start date: March 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: March 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: September 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect
• Neurotoxicity Syndromes

Intervention

Drug:
• Anesthesia Agent
various anesthetic agents used in both general and regional anesthesia

Locations

Country	Name	City	State
Egypt	Tanta University, Faculty of Medicine	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	olfactory identification	We will use UPSIT test.	Smell identification will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative
Secondary	cognitive dysfunction	cognitive dysfunction will be evaluated by mini-mental state examination	Cognitive dysfunction will be evaluated at 12 hours preoperative then at 6, 24 and 48 hours postoperative
Secondary	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