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

Postoperative Cognitive Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06353516
• Other study ID #: 2310-117-126
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Chung-Ang University Gwangmyeong Hospital
• Contact: Wongook Wi, M.D.
• Phone: 02-2222-1553
• Email: hestia.w[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction

Intervention

Drug:
• Propofol
delivered via intravenous route
• Sevoflurane
delivered via inhalation route

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University Gwangmyeong Hospital	Gwangmyeong	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Chung-Ang University Gwangmyeong Hospital	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Concentration of serum TNFa levels	Levels of TNFa 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	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