Reducing postoperative delirium in elderly patients through medication

Modulating Surgery-Induced Blood-Brain Barrier Disruption in Elderly: Impact of Dexmedetomidine and Lidocaine, a Randomized Controlled Trial

This study is testing whether the medications dexmedetomidine and lidocaine can help prevent confusion and memory problems in older patients after they have surgery for pancreatic issues.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Samsung Medical Center (Academic / other)
• Locations: 1 site (Seoul)
• Trial ID: NCT06090955 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of dexmedetomidine and lidocaine on postoperative delirium in elderly patients undergoing elective open pancreatoduodenectomy. The study aims to compare the impact of these medications on surgery-induced blood-brain barrier disruption against a control group receiving normal saline. By focusing on the role of neuroinflammation and blood-brain barrier integrity, the trial seeks to identify potential interventions that could mitigate cognitive decline following surgery. Participants will be monitored for changes in cognitive function and delirium incidence postoperatively.

Who should consider this trial

Good fit: Ideal candidates for this study are elderly patients classified as ASA physical status I-III who are scheduled for elective open pancreatoduodenectomy.

Not a fit: Patients with certain cardiac conditions, severe obesity, or contraindications to the study drugs will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of postoperative delirium and improve cognitive outcomes for elderly patients after surgery.

How similar studies have performed: Previous studies have indicated that similar approaches using dexmedetomidine and lidocaine have shown promise in reducing postoperative complications, suggesting potential success for this trial.

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

Where this trial is running

Seoul

• Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)

Study contacts

• Principal investigator: Jiseon Jeong — Samsung Medical Center
• Study coordinator: jeayoun kim

Conditions Delirium, Postoperative; Postoperative delirium; dexmedetomidine; lidocaine; neuroinflammation; CPAR; blood brain barrier