Comparing melatonin and lidocaine to reduce postoperative delirium in elderly hip surgery patients
Official title: 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
Run by Tanta University · NCT06768580 · Data updated 2026-11-12
This study is testing whether giving melatonin or using lidocaine during hip surgery can help older patients avoid confusion after their operation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 135 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Status | Recruiting |
| Started | January 15, 2025 |
| Main results expected | October 1, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | April 15, 2025 |
| Trial ID | NCT06768580 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are elderly patients over 65 years old, undergoing unilateral total hip arthroplasty with a BMI between 18-30.
✕Probably not a fit
Patients with a history of mental illness, serious cardiovascular diseases, or those on CNS medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of oral melatonin versus intraoperative lidocaine infusion in reducing the incidence of postoperative delirium in elderly patients undergoing total hip arthroplasty under spinal anesthesia. Delirium is a common complication in this demographic, with prevalence rates ranging from 20% to 45%. The study will involve elderly patients aged over 65 with specific inclusion and exclusion criteria, assessing the impact of these interventions on their cognitive outcomes post-surgery. The research will provide insights into potential preventive measures for postoperative delirium in high-risk surgical patients.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of postoperative delirium, improving recovery and quality of life for elderly patients after hip surgery.
How similar studies have gone: While the use of melatonin for postoperative delirium is promising, this specific comparison with lidocaine infusion is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Tanta University
Tanta, El-Gharbia, Egypt Recruiting
Study contacts
- Study coordinator: Alshaimaa S Alasrag, Master
- Email: alshaimaa.alasrag@med.tanta.edu.eg
- Phone: 00201018940354
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.