Neurotoxicity of Anesthesia in Middle Aged Patients

NCT04275531 | Unknown DMC

• 1 other identifier: neurotoxicity of anesthesia
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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

Conditions

Anesthesia; Adverse Effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• olfactory identification

  Smell identification will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative

• cognitive dysfunction

  Cognitive dysfunction will be evaluated at 12 hours preoperative then at 6, 24 and 48 hours postoperative

• serum melatonin concentrations

  serum melatonin will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative

Study Arms (4)

regional anesthesia

surgical procedures which will be performed under intrathecal anesthesia without sedation

Drug: Anesthesia Agent

sevoflurane

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

Drug: Anesthesia Agent

isoflurane

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

Drug: Anesthesia Agent

propofol

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

Drug: Anesthesia Agent

Interventions

Anesthesia Agent DRUG

various anesthetic agents used in both general and regional anesthesia

Also known as: Sevoflurane, Isoflurane, Propofol infusion

isoflurane; propofol; regional anesthesia; sevoflurane

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University, Faculty of Medicine

Tanta, 31527, Egypt

Location

MeSH Terms

Interventions

Anesthetics; Sevoflurane; Isoflurane

Intervention Hierarchy (Ancestors)

Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Mona R Elghamry, MD

  Tanta University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 19, 2020
• Study Start: March 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Individual patient data will be shared after finishing and publication of the study and it will be available for 6 months.
• Access Criteria: 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)

Locations

EG (1)