Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, Gyeonggi-do, 14353, South Korea
NCT Number: NCT06353516
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
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Notify Me60 year and older
All sexes
Interventional
Not applicable
Gwangmyeong, Gyeonggi-do, 14353, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
delivered via intravenous route
delivered via inhalation route
Time frame: before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
Levels of S100B will be obtained from venous blood samples collected before surgery, at the end of surgery, 4 hours after surgery, and 1st day after surgery.
Time frame: during 7 postoperative days or until discharge if the postoperative hospital stay is shorter than 7 days
Investigators will investigate the occurrence of Delirium using CAM or CAM-ICU (in case of ICU admission). during 7 postoperative days or until discharge if the postoperative hospital stay is shorter than 7 days.
Time frame: before surgery, 3 months after surgery
The T-MOCA is a validated cognitive function test. The investigators will investigate changes in T-MOCA between baseline and 3 months after surgery.
Time frame: before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
Levels of albumin will be obtained from venous blood samples collected before surgery, at the end of surgery, 4 hours after surgery, and 1st day after surgery.
Time frame: before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
Levels of CRP will be obtained from venous blood samples collected before surgery, at the end of surgery, 4 hours after surgery, and 1st day after surgery.
Time frame: before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
Levels of IL6 will be obtained from venous blood samples collected before surgery, at the end of surgery, 4 hours after surgery, and 1st day after surgery.
Time frame: before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
Levels of TNFα will be obtained from venous blood samples collected before surgery, at the end of surgery, 4 hours after surgery, and 1st day after surgery.
Time frame: Within 24 hour before surgery, at the end of surgery
(in case of schedulled ICU admission) Levels of albumin will be obtained from CSF samples collected before surgery, at the end of surgery in case of schedulled ICU admission.
Chung-Ang University Gwangmyeong Hospital
Other
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
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