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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Egypt
Tanta University
RECRUITING
Tanta
Contact Information
Primary
Alshaimaa S Alasrag, Master
alshaimaa.alasrag@med.tanta.edu.eg
00201018940354
Time Frame
Start Date: 2025-01-15
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 135
Treatments
Experimental: Melatonin group
Patients will receive one capsule of melatonin (5mg) orally the night before surgery at 9 pm, the night of the operation, and two nights after the surgical operation at 9 pm, also the patients will receive 10 ml bolus of saline intravenous (IV) over 10 min before induction of anesthesia, then continuous infusion of saline (20 ml/hr) until the end of surgery.
Experimental: Lidocaine group
Patients will receive a bolus (10 ml) of intravenous lidocaine (1mg/kg) diluted with saline over 10 min before induction of anesthesia. Continuous infusion of 1.5 mg/kg/hr of intravenous lidocaine diluted with saline (20 ml/hr) will be administered until the end of the surgery, also will receive placebo capsule the night before surgery at 9 pm, the night of operation and two nights after the surgical operation at 9 pm.
Placebo_comparator: Control group
Patients will receive a bolus (10 ml) of saline over 10 min before induction of anesthesia, then continuous infusion of saline (20 ml/hr) and placebo capsule the night before surgery at 9 pm, the night of the operation and two nights after the surgical operation at 9 pm.
Related Therapeutic Areas
Sponsors
Leads: Tanta University