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| Name | Class |
|---|---|
| National Research Foundation of Korea | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Anesthesia | Active Comparator | The anesthesia is maintained with intravenous anesthetics |
|
| Inhaled Gas Anesthesia | Sham Comparator | The anesthesia is maintained with inhaled gas anesthetics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | delivered via intravenous route |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eun Jung Oh, M.D., Ph.D. | Chung-Ang University Gwangmyeong Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Gwangmyeong Hospital | Gwangmyeong | Gyeonggi-do | 14353 | South Korea |
Individual participant data that underlies the results of this study will be made available upon reasonable request, after deidentification (text, tables, figures, and appendices).
Beginning 3 months and ending 5 years following article publication
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.
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| ID | Term |
|---|---|
| D000079690 | Postoperative Cognitive Complications |
| D000090862 | Neuroinflammatory Diseases |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D060825 | Cognitive Dysfunction |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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The participants are randomly assigned to total intravenous anesthesia group or inhaled gas anesthesia group
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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.
| Sevoflurane |
| Drug |
delivered via inhalation route |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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. | 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. | Within 24 hour before surgery, at the end of surgery |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009422 | Nervous System Diseases |
| D007249 | Inflammation |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |