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Recruiting Not applicable

Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty

NCT06768580 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-01-15
Last updated
2025-04-15

Condition(s) studied

Oral MelatoninLidocaine InfusionPostoperative DeliriumElderly PatientsTotal Hip Arthroplasty

Investigational drug(s) / intervention(s)

Melatonin →Lidocaine →Placebo

Melatonin: 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.

Lidocaine: 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.

Placebo: 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.

Study 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

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

  • The incidence of postoperative delirium (POD) — 1st five days postoperatively
    Incidence of postoperative delirium in elderly patients undergoing total hip arthroplasty will be recorded

Trial sites (1)

FacilityCityRegionStatus
Tanta University Tanta El-Gharbia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06768580 on ClinicalTrials.gov ↗ ← All trials in Egypt