Status:
RECRUITING
Modulating Surgery-Induced Blood-Brain Barrier Disruption in Elderly
Lead Sponsor:
Samsung Medical Center
Conditions:
Delirium, Postoperative
Eligibility:
All Genders
65+ years
Phase:
NA
Brief 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 neuroinf...
Detailed Description
Postoperative delirium (POD) negatively affects cognitive domains including memory, attention, and concentration after surgery. The incidence of POD in high-risk populations, such as aged, patients in...
Eligibility Criteria
Inclusion
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Undergoing elective open pancreatoduodenectomy
- Voluntary participation in the trial and signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06090955
Start Date
October 25 2023
End Date
December 31 2024
Last Update
April 17 2024
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 06351