Neurotoxicity of Anesthesia in Middle Aged Patients

Sponsor
Tanta University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04275531
Collaborator
(none)
600
1
18
33.3

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Anesthesia Agent

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Possible Neurotoxicity of Anesthesia Guided by Olfactory Changes in Middle-aged Patients
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
regional anesthesia

surgical procedures which will be performed under intrathecal anesthesia without sedation

Drug: Anesthesia Agent
various anesthetic agents used in both general and regional anesthesia
Other Names:
  • Sevoflurane
  • Isoflurane
  • Propofol infusion
  • sevoflurane

    surgical procedures which will be performed under general anesthesia and sevoflurane will be used for maintenance of anesthesia

    Drug: Anesthesia Agent
    various anesthetic agents used in both general and regional anesthesia
    Other Names:
  • Sevoflurane
  • Isoflurane
  • Propofol infusion
  • isoflurane

    surgical procedures which will be performed under general anesthesia and isoflurane will be used for maintenance of anesthesia

    Drug: Anesthesia Agent
    various anesthetic agents used in both general and regional anesthesia
    Other Names:
  • Sevoflurane
  • Isoflurane
  • Propofol infusion
  • propofol

    surgical procedures which will be performed under general anesthesia and propofol infusion will be used for maintenance of anesthesia

    Drug: Anesthesia Agent
    various anesthetic agents used in both general and regional anesthesia
    Other Names:
  • Sevoflurane
  • Isoflurane
  • Propofol infusion
  • Outcome Measures

    Primary Outcome Measures

    1. olfactory threshold [olfactory threshold will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative]

      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.

    Secondary Outcome Measures

    1. olfactory identification [Smell identification will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative]

      We will use UPSIT test.

    2. cognitive dysfunction [Cognitive dysfunction will be evaluated at 12 hours preoperative then at 6, 24 and 48 hours postoperative]

      cognitive dysfunction will be evaluated by mini-mental state examination

    3. serum melatonin concentrations [serum melatonin will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative]

      Melatonin levels will be measured in plasma by the enzyme-linked immunosorbent assay (ELISA)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanta University, Faculty of Medicine Tanta Egypt 31527

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • Principal Investigator: Mona R Elghamry, MD, Tanta University, Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mona Raafat Elghamry, principal investigator, Tanta University
    ClinicalTrials.gov Identifier:
    NCT04275531
    Other Study ID Numbers:
    • neurotoxicity of anesthesia
    First Posted:
    Feb 19, 2020
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 15, 2022