Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353516
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-02-13
Brief Title:
The Effect of Intravenous Versus Volatile Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients
Sponsor:
Chung-Ang University Gwangmyeong Hospital
Organization:
Chung-Ang University Gwangmyeong Hospital
Study Overview
Official Title:
Evaluation of the Effect of Intravenous Anesthesia Versus Volatile Anesthesia on Blood-brain Barrier Permeability and Neuroinflammation Affecting Postoperative Cognitive Dysfunction in Elderly Patients A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare the permeability of blood-brain barrier between the intravenous anesthesia group and the inhalation gas anesthesia group in the elderly patients undergoing surgery The main questions it aims to answer are
Is the permeability of blood-brain barrier between the intravenous anesthesia group and the inhalation gas anesthesia group in the elderly patients different
Is the incidence of postoperative cognitive dysfunction between the intravenous anesthesia group and the inhalation gas anesthesia group different Participants will be anesthetized with different categories of anesthetics
Intravenous anesthetics
Inhalation gas anesthetics
Is the permeability of blood-brain barrier between the intravenous anesthesia group and the inhalation gas anesthesia group in the elderly patients different
Is the incidence of postoperative cognitive dysfunction between the intravenous anesthesia group and the inhalation gas anesthesia group different Participants will be anesthetized with different categories of anesthetics
Intravenous anesthetics
Inhalation gas anesthetics
Detailed Description:
This clinical trial targets patients aged 60 years or older with American Society of Anesthesiologists physical status ASA 1 to 3 who undergo surgery under general anesthesia at our hospital Before entering the operating room patients are randomly assigned to the intravenous anesthesia group and the inhalation gas anesthesia group The intravenous anesthesia group uses propofol for anesthesia and the inhalation gas anesthesia group uses sevoflurane A 3 mL blood sample is collected four times before surgery at the end of surgery 4 hours after surgery and 1st day after surgery All blood samples will be immediately transferred to the department of Laboratory medicine and stored at -80 degree Pre-scheduled tests to determine the brain-blood barrier permeability and inflammatory cytokines will be conducted after the recruitment of all samples In addition for patients scheduled to be transferred to the intensive care unit ICU after surgery among the study subjects a 3 mL of cerebrospinal fluid sample is collected two times before surgery and at the end of surgery The same preservation protocol will be applied to the cerebrospinal fluid samples All study subjects will be monitored for postoperative delirium daily for up to 7 days after surgery or until discharge Cognitive function is assessed using telephone version of the Montreal Cognitive Assessment T-MOCA before surgery and 3 months after surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None