Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty
Launched by TANTA UNIVERSITY · Jan 6, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how well oral melatonin and a lidocaine infusion can help prevent confusion and disorientation, known as postoperative delirium, in older patients undergoing hip replacement surgery. Delirium is a common problem after surgery, especially in people over 65, and this study is comparing two methods to see which one might be more effective in reducing this issue.
To be eligible for the trial, patients must be over 65 years old and scheduled for a specific type of hip surgery called unilateral total hip arthroplasty. They should also have a healthy weight and not have serious heart, brain, or liver problems, among other health conditions. If you or a loved one participates, you can expect to receive either melatonin or lidocaine during the surgery, and researchers will monitor how this affects your recovery and mental clarity afterward. The trial is currently recruiting participants, and it's a chance to contribute to important research that may help improve care for elderly patients in the future.
Gender
ALL
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.
About Tanta University
Tanta University is a prestigious academic institution located in Egypt, dedicated to advancing medical research and education. As a clinical trial sponsor, Tanta University leverages its extensive resources and expertise to conduct innovative research initiatives aimed at improving health outcomes. The university collaborates with a network of healthcare professionals, researchers, and institutions to facilitate rigorous clinical trials across various medical disciplines. Committed to ethical standards and scientific integrity, Tanta University strives to contribute to the global body of knowledge while fostering the next generation of medical professionals.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tanta, , Egypt
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported