Abdominal Surgeries, Cerebral Oxygen Saturation, Dexmedetomidine, Elderly Patients, Intraoperative Infusion, Lidocaine, Postoperative Delirium
Conditions
Brief summary
This study aims to compare the effect of intraoperative infusion of either lidocaine or dexmedetomidine on the incidence of postoperative delirium (POD) in elderly patients undergoing major surgeries. It also aims to evaluate the impact of both medications on intraoperative regional cerebral oxygen saturation (rSO₂).
Detailed description
Postoperative delirium (POD) is a significant complication in elderly patients undergoing major surgery, with an incidence ranging from 10% to 50%, depending on patient and surgical factors. Regional cerebral oxygen saturation (rSO₂), measured using near-infrared spectroscopy (NIRS), provides a real-time, non-invasive marker of cerebral perfusion. Previous studies have demonstrated that intraoperative declines in rSO₂ are associated with an increased risk of POD. Lidocaine, an amide local anesthetic, has been shown to reduce neuroinflammation, improve microcirculation, and exert neuroprotective effects. It has been associated with low postoperative pain, reduced opioid consumption, and improved cognitive outcomes. Dexmedetomidine, an α2-adrenergic agonist, is known for its sedative, analgesic, and sympatholytic effects. It has been shown to enhance cerebral perfusion, improve rSO₂, and reduce POD incidence.
Interventions
DRUGLidocaine
Patients will receive an IV bolus (50 ml) of lidocaine (1mg/kg) diluted with saline over 10 min before induction of anesthesia. This will be followed by intraoperative lidocaine infusion in a dose of 1.5mg /kg/hr till the end of surgery.
DRUGDexmedetomidine
Patients will receive an IV bolus (50 ml) of dexmedetomidine in dose 0.5 μg/kg over 10 min before induction of anesthesia. This will be followed by intraoperative dexmedetomidine infusion in a dose of 0.3 μg/kg/hr till the end of surgery.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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 \[e.g., allergy, severe bradycardia, atrioventricular (AV) block\].
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative delirium | Three days after surgery | Incidence of postoperative delirium (POD) will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain | 24 hours postoperatively | Postoperative numerical rate scale (NRS) score will be recorded on admission to the post-anesthesia care unit (PACU), at six h, 12h, and 24h postoperatively. |
| Postoperative opioid consumption | 24 hours postoperatively | Rescue analgesia in the from 3 mg IV morphine (mg) will be given if the numerical rate scale (NRS) is ≥ 4 repeated with 10 10-minute lock-out interval till the NRS becomes less than 3. |
| Regional cerebral oxygen saturation | Till end of surgery (Up to 2 hours) | Regional cerebral oxygen saturation (rScO2) will be recorded using cerebral oximetry at the baseline, 5 min after induction of general anesthesia, then every 20 min till the end of surgery. |
| Mean arterial blood pressure | Till end of surgery (Up to 2 hours) | Mean arterial blood pressure will be recorded at baseline, after induction, after 15 min, then every 15 min till the end of surgery. |
| Incidence of adverse effects | 24 hours postoperatively | Incidence of adverse effects such as nausea, vomiting, and respiratory depression will be recorded. |
| Heart rate | Till end of surgery (Up to 2 hours) | Heart rate will be recorded at baseline, after induction, after 15 min, then every 15 min till the end of surgery. |
Countries
Egypt
Contacts
Primary ContactDina H Alhassanin, Master
Outcome results
None listed