Modulating Surgery-Induced Blood-Brain Barrier Disruption in Elderly

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Postoperative delirium (POD) is the most common complications (~50-60%) in elderly and major challenges to our rapidly growing aging population. Growing evidence suggests a possible role for neuroinflammation in the development of delirium, which is facilitated by a transient increase in blood-brain barrier (BBB) permeability. Lidocaine and dexmedetomidine, commonly used anesthetic adjuncts, have anti-inflammatory properties. Both drugs are reported to have modulatory effect on the intergrity of BBB and associated with a beneficial effect on postoperative neurocognitive dysfunction. In this regard, The investigators aimed to prospectively compare the modulatory effect of the intraoperative administration of dexmedetomidine or lidocaine with a sham control group (normal saline solution) on surgery-induced BBB disruption.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Dexmedetomidine; Lidocaine

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