Lidocaine versus dexmedetomidine during abdominal surgery to protect brain oxygen and reduce delirium in older adults
Effect of Intraoperative Infusion of Either Lidocaine or Dexmedetomidine on Regional Cerebral Oxygen Saturation and Postoperative Delirium in Elderly Patients Undergoing Abdominal Surgeries
This trial tests whether giving lidocaine or dexmedetomidine during major abdominal surgery helps keep brain oxygen levels stable and reduces postoperative delirium in people aged 65 and older.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT07108764 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares intraoperative intravenous infusions of lidocaine or dexmedetomidine in patients aged 65 and older undergoing elective major abdominal surgery. Regional cerebral oxygen saturation (rSO₂) will be monitored continuously with near-infrared spectroscopy during the procedure. Investigators will record the incidence of postoperative delirium (POD) and relate it to intraoperative rSO₂ changes and the assigned medication. Patients with major organ dysfunction, preexisting cognitive or psychiatric disorders, or contraindications to the study drugs are excluded.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 or older, ASA II–III, scheduled for elective non-cardiac major abdominal surgery without severe renal or hepatic dysfunction, no significant preexisting cognitive or psychiatric illness, and no contraindication to lidocaine or dexmedetomidine.
Not a fit: Patients with preexisting dementia or psychiatric illness, those taking central nervous system medications, those with severe organ dysfunction, or those with contraindications to lidocaine or dexmedetomidine are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the approach could lower the risk of postoperative delirium and better preserve brain oxygenation during surgery for older patients.
How similar studies have performed: Previous studies have suggested lidocaine may reduce neuroinflammation and that dexmedetomidine can improve cerebral perfusion and lower rates of postoperative delirium, so this approach has supporting but not definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 65years old. * Both sexes. * Physical status classification of II - III according to the American Society of Anesthesiologists (ASA). * Undergo elective non-cardiac surgeries. Exclusion Criteria: * History of mental illness, neurological illness, or scoring less than 8 using the abbreviated mental test (AMT) before operation. * Severe hearing or visual impairment that may interfere with communication. * Severe renal or hepatic dysfunction. * Patients on central nervous system (CNS) medications (antipsychotics, anticonvulsants, antiparkinsonian, antidepressants). * Contraindications to lidocaine or dexmedetomidine \[e.g., allergy, severe bradycardia, atrioventricular (AV) block\].
Where this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Dina H Alhassanin, Master
- Email: dhamdy420@gmail.com
- Phone: 00201143441294
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.