NCT06768580 Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty
| NCT ID | NCT06768580 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tanta University |
| Condition | Oral Melatonin |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 135 participants in total. It began in 2025-01-15 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06768580 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Oral Melatonin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06768580 currently recruiting?
Yes, NCT06768580 is actively recruiting participants. Contact the research team at alshaimaa.alasrag@med.tanta.edu.eg for enrollment information.
Where is the NCT06768580 trial being conducted?
This trial is being conducted at Tanta, Egypt.
Who is sponsoring the NCT06768580 clinical trial?
NCT06768580 is sponsored by Tanta University. The trial plans to enroll 135 participants.