Clinical trial NCT06353516: The Effect of Intravenous Versus Volatile Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Keywords: total intravenous anesthesia
inhaled gas anesthesia
blood-brain barrier permeability
neuroinflammation
delirium
postoperative cognitive dysfunction
Lead sponsor: Chung-Ang University Gwangmyeong Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2024-04-09
Enrollment: 154
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants are randomly assigned to total intravenous anesthesia group or inhaled gas anesthesia group
Primary purpose: PREVENTION

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

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.

Eligibility criteria: Inclusion Criteria:

* age equal to or older than 60
* american Society of Anesthesiologists (ASA) grade I to III
* general anesthesia longer than 2 hours

Exclusion Criteria:

* history of dementia
* history of schizophrenia, epilepsy, or Parkinson's disease
* history of stroke or craniectomy
* patient denial

Primary outcomes:
measure: Concentration of serum S100B levels
timeFrame: before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
Secondary outcomes:
measure: Incidence of Delirium
timeFrame: during 7 postoperative days or until discharge if the postoperative hospital stay is shorter than 7 days
measure: Incidence of Postoperative Cognitive Dysfunction
timeFrame: before surgery, 3 months after surgery
measure: Concentration of serum albumin
timeFrame: before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
measure: Concentration of serum CRP
timeFrame: before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
measure: Concentration of serum IL6 levels
timeFrame: before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
measure: Concentration of serum TNFα levels
timeFrame: before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
measure: Concentration of cerebrospinal fluid (CSF) albumin
timeFrame: Within 24 hour before surgery, at the end of surgery
Other outcomes:
Locations:
city: Gwangmyeong
country: Korea, Republic of
facility: Chung-Ang University Gwangmyeong Hospital
state: Gyeonggi-do
Study officials:
affiliation: Chung-Ang University Gwangmyeong Hospital
name: Eun Jung Oh, M.D., Ph.D.
role: STUDY_DIRECTOR
References: