Actively Recruiting
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
Led by Tanta University · Updated on 2025-04-15
135
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of oral melatonin compared to intraoperative lidocaine infusion on the occurrence of postoperative delirium in elderly patients undergoing total hip arthroplasty with spinal anesthesia. Postoperative delirium is a common condition in this population, characterized by sudden disturbances in attention and awareness, often fluctuating in severity and appearing within five days after surgery. The study aims to better understand how these treatments may influence delirium incidence and related outcomes in this high-risk group. Participants are assigned to one of three groups: one receiving oral melatonin capsules at 9 pm the night before surgery, the night of surgery, and for two nights after surgery along with intravenous saline during surgery; another receiving intravenous lidocaine starting with a bolus before anesthesia induction and continuous infusion during surgery, plus placebo capsules; and a control group receiving saline infusions and placebo capsules at the same times. The treatments are administered before and during surgery, with monitoring continuing through the postoperative period. During the study, researchers will monitor participants for postoperative delirium incidence, severity, onset, and duration over the first five days after surgery. They will also assess pain levels 24 hours after surgery, hospital stay length, and any adverse effects within 24 hours postoperatively. Participants undergo assessments including mental testing before surgery and close observation after surgery to capture these outcomes. The total duration of participation includes the preoperative dosing and the postoperative monitoring period, extending up to hospital discharge.
CONDITIONS
Brief Title
Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Elderly patients aged >65 years old undergoing unilateral total hip arthroplasty.
- Patients with body mass index (BMI) between 18 and 30 kg/m2.
- American Society of Anesthesiologists (ASA) physical status I-III, scheduled to undergo unilateral total hip arthroplasty.
You will not qualify if you...
- History of mental illness or scoring less than 8 using abbreviated mental test before operation.
- Obvious sinus bradycardia (heart rate <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 or electrolyte disturbances.
- Alcohol dependence or drug abuse.
- Redo surgery or infectious complications.
- Use of CNS medications like antipsychotics, anticonvulsants, antiparkinsonian drugs, or antidepressants.
- History of deep vein thrombosis.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive oral melatonin or intravenous lidocaine infusion during surgery, or placebo. Melatonin or placebo capsules are taken the night before surgery, the night of surgery, and for two nights after surgery. Intravenous infusions are administered before and during surgery.
1 surgery visit and 3 nighttime medication administrations
Duration - Up to 2 weeks
Participants are monitored for postoperative delirium, pain, adverse effects, and length of hospital stay for up to 2 weeks after surgery.
Daily visits for up to 5 days postoperatively and additional visits until hospital discharge
Trial Site Locations
Total: 1 location
1
Tanta University
Tanta, El-Gharbia, Egypt, 31527
Actively Recruiting
Research Team
A
Alshaimaa S Alasrag, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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