Neurotoxicity of Anesthesia in Middle Aged Patients

NCT ID: NCT04275531

Last Updated: 2022-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia; Adverse Effect

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

regional anesthesia

surgical procedures which will be performed under intrathecal anesthesia without sedation

Anesthesia Agent

Intervention Type DRUG

various anesthetic agents used in both general and regional anesthesia

sevoflurane

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

Anesthesia Agent

Intervention Type DRUG

various anesthetic agents used in both general and regional anesthesia

isoflurane

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

Anesthesia Agent

Intervention Type DRUG

various anesthetic agents used in both general and regional anesthesia

propofol

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

Anesthesia Agent

Intervention Type DRUG

various anesthetic agents used in both general and regional anesthesia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anesthesia Agent

various anesthetic agents used in both general and regional anesthesia

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sevoflurane Isoflurane Propofol infusion

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mona Raafat Elghamry

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mona R Elghamry, MD

Role: PRINCIPAL_INVESTIGATOR

Tanta University, Faculty of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tanta University, Faculty of Medicine

Tanta, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

neurotoxicity of anesthesia

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.