The Effect of Intravenous Versus Volatile Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients

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

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Cognitive Dysfunction
• Intervention / Treatment: Drug: Propofol; Drug: Sevoflurane

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 Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wongook Wi, M.D.; Phone Number: 02-2222-1553; Email: hestia.w@gmail.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Gwangmyeong, Gyeonggi-do, Korea, Republic of, 14353
      • Recruiting
      • Chung-Ang University Gwangmyeong Hospital
      • Contact: Wongook Wi, M.D.; Phone Number: 02-2222-1553; Email: hestia.w@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous Anesthesia; The anesthesia is maintained with intravenous anesthetics	Drug: Propofol; delivered via intravenous route
Sham Comparator: Inhaled Gas Anesthesia; The anesthesia is maintained with inhaled gas anesthetics	Drug: Sevoflurane; delivered via inhalation route

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of serum S100B levels	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.	before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Delirium	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.	during 7 postoperative days or until discharge if the postoperative hospital stay is shorter than 7 days
Incidence of Postoperative Cognitive Dysfunction	The T-MOCA is a validated cognitive function test. The investigators will investigate changes in T-MOCA between baseline and 3 months after surgery.	before surgery, 3 months after surgery
Concentration of serum albumin	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.	before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
Concentration of serum CRP	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.	before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
Concentration of serum IL6 levels	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.	before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
Concentration of serum TNFα levels	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.	before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
Concentration of cerebrospinal fluid (CSF) albumin	(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.	Within 24 hour before surgery, at the end of surgery

Collaborators and Investigators

• Sponsor: Chung-Ang University Gwangmyeong Hospital
• Collaborators: National Research Foundation of Korea
• Investigators: Study Director: Eun Jung Oh, M.D., Ph.D., Chung-Ang University Gwangmyeong Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: delirium; postoperative cognitive dysfunction; total intravenous anesthesia; neuroinflammation; inhaled gas anesthesia; blood-brain barrier permeability
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: 2310-117-126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlies the results of this study will be made available upon reasonable request, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication
• IPD Sharing Access Criteria: Data will be available to researchers who provide a methodologically sound proposal to the corresponding author of the article. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No