Clinical trial Recruiting at 1 site Interventional Ages 65 and up

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.

More Postoperative Delirium trials

Quick facts

Study typeInterventional
Ages65 Years and up
SexAll
Enrollment135 (estimated)
SponsorTanta University
Academic / other
Locations1 site (Tanta, El-Gharbia)
StatusRecruiting
StartedJanuary 15, 2025
Main results expectedOctober 1, 2026
Study endsOctober 1, 2026
Registry record updatedApril 15, 2025
Trial IDNCT06768580 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

  • Tanta University
    Tanta, El-Gharbia, Egypt
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.