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

NCT06353516 | Completed DMC

• 1 other identifier: 2310-117-126
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Cognitive Dysfunction

Keywords

total intravenous anesthesia; inhaled gas anesthesia; blood-brain barrier permeability; neuroinflammation; delirium; postoperative cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence of Delirium

  during 7 postoperative days or until discharge if the postoperative hospital stay is shorter than 7 days

• Incidence of Postoperative Cognitive Dysfunction

  before surgery, 3 months after surgery

• Concentration of serum albumin

  before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery

• Concentration of serum CRP

  before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery

• Concentration of serum IL6 levels

  before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery

Study Arms (2)

Intravenous Anesthesia

ACTIVE COMPARATOR

The anesthesia is maintained with intravenous anesthetics

Drug: Propofol

Inhaled Gas Anesthesia

SHAM COMPARATOR

The anesthesia is maintained with inhaled gas anesthetics

Drug: Sevoflurane

Interventions

Propofol DRUG

delivered via intravenous route

Intravenous Anesthesia

Sevoflurane DRUG

delivered via inhalation route

Inhaled Gas Anesthesia

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chung-Ang University Gwangmyeong Hospital: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Gyeonggi-do, 14353, South Korea

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications; Neuroinflammatory Diseases; Delirium

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Nervous System Diseases; Inflammation; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Eun Jung Oh, M.D., Ph.D.

  Chung-Ang University Gwangmyeong Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is a double-blinded randomized controlled trial. The group assignment is conducted by the pre-generated random number table. The participant, investigator and the outcome assessor are blinded to the group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The participants are randomly assigned to total intravenous anesthesia group or inhaled gas anesthesia group

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: April 9, 2024
• Study Start: February 14, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication
• 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.

Locations

KR (1)