Comparing melatonin and lidocaine to reduce postoperative delirium in elderly hip surgery patients
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
This study is testing whether giving melatonin or using lidocaine during hip surgery can help older patients avoid confusion after their operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT06768580 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with a history of mental illness, serious cardiovascular diseases, or those on CNS medications may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Alshaimaa S Alasrag, Master
- Email: alshaimaa.alasrag@med.tanta.edu.eg
- Phone: 00201018940354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.