Postoperative Cognitive Dysfunction
Conditions
Keywords
total intravenous anesthesia, inhaled gas anesthesia, blood-brain barrier permeability, neuroinflammation, delirium, postoperative cognitive dysfunction
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
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.
Interventions
DRUGPropofol
delivered via intravenous route
DRUGSevoflurane
delivered via inhalation route
Sponsors
Chung-Ang University Gwangmyeong Hospital
National Research Foundation of Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
The participants are randomly assigned to total intravenous anesthesia group or inhaled gas anesthesia group
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of serum S100B levels | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Delirium | 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. |
| Incidence of Postoperative Cognitive Dysfunction | 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. |
| Concentration of serum albumin | 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. |
| Concentration of serum CRP | 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. |
| Concentration of serum IL6 levels | 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. |
| Concentration of serum TNFα levels | 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. |
| Concentration of cerebrospinal fluid (CSF) albumin | 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. |
Countries
South Korea
Contacts
STUDY_DIRECTOREun Jung Oh, M.D., Ph.D.
Chung-Ang University Gwangmyeong Hospital
Outcome results
None listed