About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 65years old.
Both sexes.
Physical status classification of II - III according to the American Society of Anesthesiologists (ASA).
Undergo elective non-cardiac surgeries.
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
Lidocaine
DrugPatients 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.
Dexmedetomidine
DrugPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of postoperative delirium
Incidence of postoperative delirium (POD) will be recorded.
Secondary outcomes
Regional cerebral oxygen saturation
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.
Degree of pain
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
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.
Heart rate
Heart rate will be recorded at baseline, after induction, after 15 min, then every 15 min till the end of surgery.
Sponsors and contacts
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