Postoperative Cognitive DysfunctionNCT06353516
The Effect of Intravenous Versus Volatile Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients
A study testing Propofol and Sevoflurane in people with Postoperative Cognitive Dysfunction, run by Chung-Ang University Gwangmyeong Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Apr 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age equal to or older than 60
- american Society of Anesthesiologists (ASA) grade I to III
- general anesthesia longer than 2 hours
Who cannot join
- history of dementia
- history of schizophrenia, epilepsy, or Parkinson's disease
- history of stroke or craniectomy
- patient denial
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, Gyeonggi-do, 14353
About this study
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
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
Read the 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.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Propofol, Sevoflurane
- Keywords
- total intravenous anesthesia, inhaled gas anesthesia, blood-brain barrier permeability, neuroinflammation, delirium, postoperative cognitive dysfunction
- Medical subject headings
- Postoperative Cognitive Complications, Neuroinflammatory Diseases, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
delivered via intravenous route
SevofluraneDrug
delivered via inhalation route
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Anesthesia | Active comparator | The anesthesia is maintained with intravenous anesthetics Receives: Drug: Propofol |
| Inhaled Gas Anesthesia | Sham comparator | The anesthesia is maintained with inhaled gas anesthetics Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 24 hour before surgery, at the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start10 Apr 2024
- Primary completion30 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants are randomly assigned to total intravenous anesthesia group or inhaled gas anesthesia group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Gwangmyeong Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Eun Jung Oh, Chung-Ang University Gwangmyeong Hospital
- Investigators
- Eun Jung Oh, M.D., Ph.D., Study director, Chung-Ang University Gwangmyeong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353516
- Sponsor's protocol ID
- 2310-117-126
- Status last verified
- May 2026
- First submitted
- 13 Feb 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlies the results of this study will be made available upon reasonable request, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06353516
- Acronym / sponsor ID
- 2310-117-126
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- total intravenous anesthesia, inhaled gas anesthesia, blood-brain barrier permeability, neuroinflammation, delirium, postoperative cognitive dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Chung-Ang University Gwangmyeong HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The participants are randomly assigned to total intravenous anesthesia group or inhaled gas anesthesia group
| Arm | Type | Receives |
|---|---|---|
| Intravenous Anesthesia | Active comparator | Drug: PropofolThe anesthesia is maintained with intravenous anesthetics |
| Inhaled Gas Anesthesia | Sham comparator | Drug: SevofluraneThe anesthesia is maintained with inhaled gas anesthetics |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age equal to or older than 60
- american Society of Anesthesiologists (ASA) grade I to III
- general anesthesia longer than 2 hours
Key exclusion criteria (4 listed)
- history of dementia
- history of schizophrenia, epilepsy, or Parkinson's disease
- history of stroke or craniectomy
- patient denial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofoldelivered via intravenous route | Drug | Intravenous Anesthesia |
| Sevofluranedelivered via inhalation route | Drug | Inhaled Gas Anesthesia |
Primary outcome
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.
7 secondary outcomes
Incidence of Delirium
Time frame: during 7 postoperative days or until discharge if the postoperative hospital stay is shorter than 7 days
Incidence of Postoperative Cognitive Dysfunction
Time frame: before surgery, 3 months after surgery
Concentration of serum albumin
Time frame: before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
Concentration of serum CRP
Time frame: before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
Concentration of serum IL6 levels
Time frame: before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
Concentration of serum TNFα levels
Time frame: before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery
Concentration of cerebrospinal fluid (CSF) albumin
Time frame: Within 24 hour before surgery, at the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlies the results of this study will be made available upon reasonable request, after deidentification (text, tables, figures, and appendices).
Related trials for Postoperative Cognitive Dysfunction
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Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eun Jung Oh, M.D., Ph.D. study director
Chung-Ang University Gwangmyeong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Sevoflurane in people with Postoperative Cognitive Dysfunction, run by Chung-Ang University Gwangmyeong Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of serum S100B levels (time frame: before surgery, at the end of surgery, 4 hours after surgery, 1st day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.