Sevoflurane General Anesthetic and Spatial Memory in Humans

Sponsor
University of Chile (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05991817
Collaborator
(none)
22
2
12.6
11
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Surgery/general anesthesia

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
22 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study of the Effect of Sevoflurane General Anesthetic on Spatial Memory in Humans
Anticipated Study Start Date :
Aug 14, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Adults 30-50 years

Procedure: Surgery/general anesthesia
Adult patients between the ages of 30 and 50 who are to undergo elective surgery under general anesthesia will have their spatial memory tested and interleukin 1beta and alpha tumor necrosis measured before and after surgery.

Outcome Measures

Primary Outcome Measures

  1. Virtual spatial memory [7th day after surgery]

    Time to reach the goal

Secondary Outcome Measures

  1. Interleukin-1beta [1st day after surgery]

    Interleukin-1beta plasma concentration

  2. Interleukin-1beta [7th day after surgery]

    Interleukin-1beta plasma concentration

  3. Interleukin-1beta [30th day after surgery]

    Interleukin-1beta plasma concentration

  4. Tumor necrosis factor alpha [1st day after surgery]

    Tumor necrosis factor alpha plasma concentration

  5. Tumor necrosis factor alpha [7th day after surgery]

    Tumor necrosis factor alpha plasma concentration

  6. Tumor necrosis factor alpha [30th day after surgery]

    Tumor necrosis factor alpha plasma concentration

  7. Virtual spatial memory [1st day after surgery]

    Time to reach the goal

  8. Virtual spatial memory [30th day after surgery]

    Time to reach the goal

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 50 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile Santiago RM Chile 7690306
2 Hospital Clinico de la Universidad de Chile Santiago RM Chile 7690306

Sponsors and Collaborators

  • University of Chile

Investigators

  • Principal Investigator: Khaleed Etchegaray, University of Chile
  • Study Director: Jamileth More, PhD, University of Chile
  • Study Director: Antonello Penna, MD, PhD, University of Chile

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Chile
ClinicalTrials.gov Identifier:
NCT05991817
Other Study ID Numbers:
  • OAIC: 1328/23
First Posted:
Aug 15, 2023
Last Update Posted:
Aug 15, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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 Aug 15, 2023