Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty
Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty: Prospective Randomized Controlled Blinded Study
Tanta University
135 participants
Jan 15, 2025
INTERVENTIONAL
Conditions
Summary
The aim of this study is to assess the effect of oral melatonin versus intraoperative lidocaine infusion on incidence of postoperative delirium in elderly patients undergoing total hip arthroplasty under spinal anesthesia.
Eligibility
Inclusion Criteria3
- Elderly patients aged \>65 years old undergoing unilateral total hip arthroplasty.
- Patients with body mass index (BMI) (18-30) kg/m2.
- American Society of Anesthesiologists (ASA) physical status I-III, scheduled to undergo unilateral total hip arthroplasty.
Exclusion Criteria10
- History of mental illness or scoring less than 8 using abbreviated mental test (AMT) before operation.
- Obvious sinus bradycardia (heart rate of \<50 beats per minute) or other serious cardiovascular diseases.
- Symptomatic cerebrovascular disease (such as previous stroke).
- History of liver and kidney dysfunction.
- Allergy to lidocaine or melatonin.
- Metabolic disorders and fluid, electrolytes disturbances.
- Alcohol dependence or drug abuse.
- Redo surgery or infectious complications.
- CNS medications (antipsychotics, anticonvulsants, antiparkinsonian, antidepressants).
- History of deep vein thrombosis.
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Interventions
Patients will receive one capsule of melatonin (5mg) orally the night before surgery at 9 pm, the night of the operation, and two nights after the surgical operation at 9 pm, also the patients will receive 10 ml bolus of saline intravenous (IV) over 10 min before induction of anesthesia, then continuous infusion of saline (20 ml/hr) until the end of surgery.
Patients will receive a bolus (10 ml) of intravenous lidocaine (1mg/kg) diluted with saline over 10 min before induction of anesthesia. Continuous infusion of 1.5 mg/kg/hr of intravenous lidocaine diluted with saline (20 ml/hr) will be administered until the end of the surgery, also will receive placebo capsule the night before surgery at 9 pm, the night of operation and two nights after the surgical operation at 9 pm.
Patients will receive a bolus (10 ml) of saline over 10 min before induction of anesthesia, then continuous infusion of saline (20 ml/hr) and placebo capsule the night before surgery at 9 pm, the night of the operation and two nights after the surgical operation at 9 pm.
Locations(1)
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NCT06768580