An interventional study of Ketamine in Postoperative Delirium and Postoperative Cognitive Dysfunction, sponsored by Istinye University. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-05-09.
Sponsored by Istinye University · Not applicable, Interventional, and Treatment
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's planned enrollment of 80 is below the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →Istinye University is the lead sponsor of 207 studies on the registry; 88 are open to participants now.
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Exclusion Criteria:
Participants receive 0.9% saline at 30 mL/hour during surgery.
Drug: Ketamine
Participants receive ketamine at 0.1 mg/kg/hour as intraoperative infusion
Drug: Ketamine
Participants receive dexmedetomidine at 0.5 mcg/kg/hour as intraoperative infusion
Drug: Ketamine
Participants receive a combination of ketamine (0.3 mg/kg/hour) and dexmedetomidine (0.5 mcg/kg/hour) as intraoperative infusion.
Drug: Ketamine
Ketamine will be administered as an intravenous infusion at 0.1 mg/kg/hour during surgery
Incidence of Postoperative Cognitive Dysfunction (POCD) Measured by MMSE
Cognitive function will be assessed using the Mini Mental State Examination (MMSE). A decrease of ≥2 points from baseline will be considered indicative of POCD.
Time frame: Baseline (preoperative), Postoperative Day 2, and Postoperative Day 15
Plan to share: No
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Istinye University