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Completed

NCT Number: NCT06353516

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

delivered via intravenous route

Sevoflurane

Drug

delivered via inhalation route

Primary outcomes

  1. Concentration of serum S100B levels

    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.

Secondary outcomes

  1. Incidence of Delirium

    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.

  2. Incidence of Postoperative Cognitive Dysfunction

    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.

  3. Concentration of serum albumin

    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.

  4. Concentration of serum CRP

    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.

  5. Concentration of serum IL6 levels

    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.

  6. Concentration of serum TNFα levels

    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.

  7. Concentration of cerebrospinal fluid (CSF) albumin

    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.

Sponsors and collaborators

Lead sponsor

Chung-Ang University Gwangmyeong Hospital

Other

Collaborators

  • National Research Foundation of Korea

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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