Clinical trial NCT05991817: Sevoflurane General Anesthetic and Spatial Memory in Humans
Official title: Study of the Effect of Sevoflurane General Anesthetic on Spatial Memory in Humans
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spatial Memory Disorder
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients bewteen 30 and 50 years old who will undergo to an elective laparoscopic surgery of cholecystectomy.

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.

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.

Primary outcomes:
measure: Virtual spatial memory
timeFrame: 1th day after surgery
Secondary outcomes:
measure: Interleukin-1beta
timeFrame: 1st day after surgery
measure: Interleukin-1beta
timeFrame: 7th day after surgery
measure: Interleukin-1beta
timeFrame: 30th day after surgery
measure: Tumor necrosis factor alpha
timeFrame: 1st day after surgery
measure: Tumor necrosis factor alpha
timeFrame: 7th day after surgery
measure: Tumor necrosis factor alpha
timeFrame: 30th day after surgery
measure: Virtual spatial memory
timeFrame: 7st day after surgery
measure: Virtual spatial memory
timeFrame: 30th day after surgery
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile
state: RM
city: Santiago
country: Chile
facility: Hospital Clinico de la Universidad de Chile
state: RM
Study officials:
affiliation: University of Chile
name: Khaleed Etchegaray
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Jamileth More, PhD
role: STUDY_DIRECTOR
affiliation: University of Chile
name: Antonello Penna, MD, PhD
role: STUDY_DIRECTOR
References: