- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05991817
Sevoflurane General Anesthetic and Spatial Memory in Humans
Study of the Effect of Sevoflurane General Anesthetic on Spatial Memory in Humans
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Antonello Penna, MD, PhD
- Phone Number: +56956766623
- Email: apenna@uchile.cl
Study Contact Backup
- Name: Khaleed Etchegaray
- Phone Number: +56973310929
- Email: khaleed.etchegaray@gmail.com
Study Locations
-
-
RM
-
Santiago, RM, Chile, 7690306
- Recruiting
- Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile
-
Contact:
- Daniela Ponce, Ing
- Phone Number: 56229789405
- Email: dponcedelavega@gmail.com
-
Santiago, RM, Chile, 7690306
- Recruiting
- Hospital Clinico de la Universidad de Chile
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adults 30-50 years
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Virtual spatial memory
Time Frame: 1th day after surgery
|
Time to reach the goal
|
1th day after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interleukin-1beta
Time Frame: 1st day after surgery
|
Interleukin-1beta plasma concentration
|
1st day after surgery
|
|
Interleukin-1beta
Time Frame: 7th day after surgery
|
Interleukin-1beta plasma concentration
|
7th day after surgery
|
|
Interleukin-1beta
Time Frame: 30th day after surgery
|
Interleukin-1beta plasma concentration
|
30th day after surgery
|
|
Tumor necrosis factor alpha
Time Frame: 1st day after surgery
|
Tumor necrosis factor alpha plasma concentration
|
1st day after surgery
|
|
Tumor necrosis factor alpha
Time Frame: 7th day after surgery
|
Tumor necrosis factor alpha plasma concentration
|
7th day after surgery
|
|
Tumor necrosis factor alpha
Time Frame: 30th day after surgery
|
Tumor necrosis factor alpha plasma concentration
|
30th day after surgery
|
|
Virtual spatial memory
Time Frame: 30th day after surgery
|
Time to reach the goal
|
30th day after surgery
|
|
Virtual spatial memory
Time Frame: 7st day after surgery
|
Time to reach the goal
|
7st day after surgery
|
Collaborators and Investigators
Sponsor
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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OAIC: 1328/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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