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

NCT ID: NCT06353516

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-14

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Cognitive Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The participants are randomly assigned to total intravenous anesthesia group or inhaled gas anesthesia group
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intravenous Anesthesia

The anesthesia is maintained with intravenous anesthetics

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

delivered via intravenous route

Inhaled Gas Anesthesia

The anesthesia is maintained with inhaled gas anesthetics

Group Type SHAM_COMPARATOR

Sevoflurane

Intervention Type DRUG

delivered via inhalation route

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Propofol

delivered via intravenous route

Intervention Type DRUG

Sevoflurane

delivered via inhalation route

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Research Foundation of Korea

OTHER

Sponsor Role collaborator

Chung-Ang University Gwangmyeong Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eun Jung Oh

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eun Jung Oh, M.D., Ph.D.

Role: STUDY_DIRECTOR

Chung-Ang University Gwangmyeong Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wongook Wi, M.D.

Role: CONTACT

02-2222-1553

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Wongook Wi, M.D.

Role: primary

02-2222-1553

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2310-117-126

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Anesthesia and Cancer Study: Colon Cancer
NCT04259398 ACTIVE_NOT_RECRUITING NA