NCT06963294

Ketamine and Dexmedetomidine for Delirium in Joint Arthroplasty

The Effect of Intraoperative Ketamine and Dexmedetomidine Use on Postoperative Delirium and Cognitive Dysfunction in Patients Undergoing Total Joint Arthroplasty

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Istinye University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effects of intraoperative ketamine and dexmedetomidine on the incidence of postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) in patients undergoing total joint arthroplasty. Given the high incidence of neurocognitive complications in elderly patients following major orthopedic surgeries, neuroprotective strategies during anesthesia are of growing interest. Both ketamine and dexmedetomidine have shown potential in reducing neuroinflammation and improving postoperative cognitive outcomes in previous studies. Eighty adult patients (ASA I-III, aged 18-100) scheduled for elective total hip or knee arthroplasty under spinal anesthesia will be randomized into four groups: control (saline infusion), ketamine infusion, dexmedetomidine infusion, and combined ketamine + dexmedetomidine. Cognitive assessments will be performed preoperatively and on postoperative days 2 and 15 using the Mini Mental State Examination (MMSE). Delirium assessments will be conducted using the Confusion Assessment Method (CAM) postoperatively on days 1, 3, and 15. Secondary outcomes include perioperative levels of cortisol, CRP, and fibrinogen, as well as postoperative pain scores (VAS) and analgesic consumption. The results are expected to clarify whether intraoperative administration of ketamine or dexmedetomidine can reduce the incidence of POD/POCD and improve postoperative recovery.

Conditions

• Postoperative Delirium
• Postoperative Cognitive Dysfunction

Interventions

Type	Name	Description
DRUG	Ketamine	Ketamine will be administered as an intravenous infusion at 0.1 mg/kg/hour during surgery

Timeline

• Start date: 2026-05-05
• Primary completion: 2026-06-15
• Completion: 2026-07-15
• First posted: 2025-05-09
• Last updated: 2025-05-09

Locations

1 site across 1 country: Turkey (Türkiye)