Modulating Surgery-Induced Blood-Brain Barrier Disruption in Elderly
Modulating Surgery-Induced Blood-Brain Barrier Disruption in Elderly: Impact of Dexmedetomidine and Lidocaine, a Randomized Controlled Trial
Samsung Medical Center
108 participants
Oct 25, 2023
INTERVENTIONAL
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.
Eligibility
Inclusion Criteria3
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Undergoing elective open pancreatoduodenectomy
- Voluntary participation in the trial and signed informed consent
Exclusion Criteria12
- 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.
- Concurrent treatment with a class 1 antiarrhythmic or amiodarone)
- History of hypersensitivity reactions or contraindications to the study drugs (dexmedetomidine or lidocaine).
- Patient at personal of familial risk of malignant hyperthermia and porphyria
- Body mass index (BMI) ˃40 kg/m2
- 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.
- History of severe hepatic (Childs-Pugh Score > Class A ) or renal (glomerular filtration rate <30m)/min×1.73m2) disorders.
- Severe audio-visual impairments, or inability to speak precluding communication.
- Evidence of preoperative delirium (Confusion Assessment Method, CAM)
- History of uncontrolled seizures.
- Patients on immunosuppressants (e.g., steroids) or immunomodulatory therapy, chemotherapeutic agents with known cognitive effects.
- Patients taking the following drugs that are moderate-strong inhibitors of the CYP1A2 and CYP3A4 metabolic pathways within 72 hours prior to surgery
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Interventions
The study drugs(dexmedetomidine 80 μg/20 mL) will be prepared with 20 mL syringe and marked as 'trial drug', which are identical in appearance with control and active comparator. In order to avoid anaesthesiologists' speculation about the randomised assignment, the study drugs will be infused at the same rate.
The study drugs(lidocaine 400 mg/20 mL) will be prepared with 20 mL syringe and marked as 'trial drug', which are identical in appearance with control and active comparator. In order to avoid anaesthesiologists' speculation about the randomised assignment, the study drugs will be infused at the same rate.
The study drugs(normal saline) will be prepared with 20 mL syringe and marked as 'trial drug', which are identical in appearance with control and active comparator. In order to avoid anaesthesiologists' speculation about the randomised assignment, the study drugs will be infused at the same rate.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06090955