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Clinical Trials/NCT05991817
NCT05991817
Recruiting
Not Applicable

Study of the Effect of Sevoflurane General Anesthetic on Spatial Memory in Humans

University of Chile2 sites in 1 country22 target enrollmentAugust 14, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spatial Memory Disorder
Sponsor
University of Chile
Enrollment
22
Locations
2
Primary Endpoint
Virtual spatial memory
Status
Recruiting
Last Updated
5 months ago

Overview

Brief Summary

The goal of this observational study is to learn about the effect of general anesthetic on spatial memory in adults who will undergo to an elective surgery. The main question it aims to answer is:

• A surgical event under general anesthesia with sevoflurane transiently impairs spatial memory in humans and induces an increase in inflammatory cytokines.

Participants will perform a virtual maze test and plasma samples will be taken before and after surgery.

Detailed Description

Postoperative cognitive dysfunction (POCD) occurs after a surgical event under general anesthesia and is characterized by a decline in one or more cognitive functions. POCD is defined as delayed neurocognitive recovery if it takes place within the first 30 days, if it exceeds that time it is known as postoperative neurocognitive disorder. The pathogenesis of this dysfunction is not entirely clear. However, the most accepted hypothesis would be neuroinflammatory, which would take place due to the contribution of inflammatory factors typical of surgical trauma under general anesthesia, with anesthetics such as sevoflurane. Consequently, one of the areas most susceptible to this inflammatory environment would be the hippocampus, a structure responsible for learning and memory. Spatial memory is responsible for encoding and retrieving information about the environment and spatial orientation. To confirm this hypothesis, an elective laparoscopic cholecystectomy under general anesthesia with sevoflurane, plasma measurement of cytokines interleukin-1beta and tumor necrosis factor-alpha and virtual navigation tests will be performed before and after an elective laparoscopic cholecystectomy under general anesthesia with sevoflurane, in order to establish a correlation between the inflammatory component and performance in the virtual navigation test. The above will allow us to elucidate the possible occurrence of a delayed neurocognitive recovery related to spatial memory in middle-aged individuals, providing new background related to an age group that has been little studied, with a non-minor incidence (30%), where the evident concern arises for being a population exposed to activities or environments of greater risk, linked to work, sport, driving, among others. This finding will guide the doctor and the patient to decide or take the necessary safeguards when proceeding with a surgical intervention in the middle-aged population.

Registry
clinicaltrials.gov
Start Date
August 14, 2023
End Date
December 30, 2025
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Chile
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Candidate for elective laparoscopic surgery of cholecystectomy.
  • Age 30 to 50 years.

Exclusion Criteria

  • Visual or hearing difficulties.
  • Malignant hyperthermia.
  • Being treated with centrally acting drugs, such as anxiolytics, antidepressants, antipsychotics, anticonvulsants, anticholinergics, and first-generation antihistamines.
  • Present a disorder of the sphere of neuropsychiatry
  • Substance abuse disorder.

Outcomes

Primary Outcomes

Virtual spatial memory

Time Frame: 1th day after surgery

Time to reach the goal

Secondary Outcomes

  • Tumor necrosis factor alpha(30th day after surgery)
  • Virtual spatial memory(30th day after surgery)
  • Interleukin-1beta(30th day after surgery)

Study Sites (2)

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