Intraoperative Infusion of Either Lidocaine or Dexmedetomidine on Regional Cerebral Oxygen Saturation and Postoperative Delirium in Elderly Patients Undergoing Abdominal Surgeries
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lidocaine, Dexmedetomidine.
- Who it may be relevant to
- Registry conditions: Intraoperative Infusion, Lidocaine, Dexmedetomidine, Cerebral Oxygen Saturation. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Intraoperative Infusion of Either Lidocaine or Dexmedetomidine on Regional Cerebral Oxygen Saturation and Postoperative Delirium in Elderly Patients Undergoing Abdominal Surgeries
Overview
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
- Drug Lidocaine
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. - Drug Dexmedetomidine
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.
Primary outcome measures
- Incidence of postoperative delirium [Time frame: Three days after surgery]
Secondary outcome measures (6)
- Regional cerebral oxygen saturation [Time frame: Till end of surgery (Up to 2 hours)]
- Degree of pain [Time frame: 24 hours postoperatively]
- Postoperative opioid consumption [Time frame: 24 hours postoperatively]
- Heart rate [Time frame: Till end of surgery (Up to 2 hours)]
- Mean arterial blood pressure [Time frame: Till end of surgery (Up to 2 hours)]
- Incidence of adverse effects [Time frame: 24 hours postoperatively]
Eligibility 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 \[e.g., allergy, severe bradycardia, atrioventricular (AV) block\].
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT07108764 · 36265MD399/4/25