Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Oral Melatonin, Lidocaine Infusion, Postoperative Delirium, Elderly Patients, Total Hip Arthroplasty

In brief

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.

Key facts

Study ID

NCT06768580

Run by

Tanta University

People needed

135

Starts

2025-01-15

Expected to finish

2026-10-01

Last updated by the study team

2025-04-15

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Tanta University — Tanta, El-Gharbia, Egypt (enrolling)

Full record on ClinicalTrials.gov

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