Modulating Surgery-Induced Blood-Brain Barrier Disruption in Elderly

Launched by SAMSUNG MEDICAL CENTER · Oct 15, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how certain medications might help prevent confusion and memory problems (known as postoperative delirium) in older adults after major surgery. Researchers are specifically looking at two commonly used drugs—lidocaine and dexmedetomidine—that may reduce inflammation in the brain and help protect the blood-brain barrier, which is a protective layer that can be affected during surgery. The study will compare the effects of these medications with a control group receiving a saline solution (a simple saltwater solution) to see if they can improve brain function after surgery.

To be eligible for this trial, participants must be between the ages of 23 and 74, be in good health according to certain medical standards, and be scheduled for a specific type of surgery called pancreatoduodenectomy. They will need to voluntarily agree to participate and provide informed consent. Participants can expect to receive either one of the study medications or the control solution during their surgery, and their recovery will be closely monitored to assess any changes in cognitive function. It's important to note that individuals with certain health conditions or those taking specific medications may not qualify for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. American Society of Anesthesiologists (ASA) physical status classification I-III
• • 2. Undergoing elective open pancreatoduodenectomy
• • 3. Voluntary participation in the trial and signed informed consent
• Exclusion Criteria:
• • 1. Sinus bradycardia (heart rate (HR) \<50 beats per minute (bpm)), Adams-Stokes syndrome, sick sinus or Wolff-Parkinson-White syndrome, or second-degree trioventricular block and over.
• • 2. Concurrent treatment with a class 1 antiarrhythmic or amiodarone)
• • 3. History of hypersensitivity reactions or contraindications to the study drugs (dexmedetomidine or lidocaine).
• • 4. Patient at personal of familial risk of malignant hyperthermia and porphyria
• • 5. Body mass index (BMI) ˃40 kg/m2
• • 6. Patients with coagulopathy (INR 1.5 or more, platelet count less than 75000/ul) or other contraindications to spinal tapping, or on anticoagulants that would preclude safe lumbar punctures.
• • 7. History of severe hepatic (Childs-Pugh Score \> Class A ) or renal (glomerular filtration rate \<30m)/min×1.73m2) disorders.
• • 8. Severe audio-visual impairments, or inability to speak precluding communication.
• • 9. Evidence of preoperative delirium (Confusion Assessment Method, CAM)
• • 10. History of uncontrolled seizures.
• • 11. Patients on immunosuppressants (e.g., steroids) or immunomodulatory therapy, chemotherapeutic agents with known cognitive effects.
• • 12. Patients taking the following drugs that are moderate-strong inhibitors of the CYP1A2 and CYP3A4 metabolic pathways within 72 hours prior to surgery