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NCT Number: NCT06963294

Ketamine and Dexmedetomidine for Delirium in Joint Arthroplasty

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled for elective total joint arthroplasty (hip or knee)
  • ASA physical status I-III
  • Age between 18 and 100 years
  • Ability to provide informed consent and comply with cognitive assessments

Exclusion criteria

  • Pre-existing cognitive dysfunction or diagnosed neurodegenerative disease
  • Hearing or language impairment interfering with MMSE/CAM evaluation
  • Known allergy to ketamine or dexmedetomidine
  • Significant cardiac arrhythmia (e.g., supraventricular tachycardia, 2nd or 3rd degree AV block)
  • Renal insufficiency (GFR <30 mL/min/1.73 m²)
  • Severe hepatic dysfunction

Treatment and study plan

ketamine

Drug

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

Primary outcomes

  1. Incidence of Postoperative Cognitive Dysfunction (POCD) Measured by MMSE

    Time frame: Baseline (preoperative), Postoperative Day 2, and Postoperative Day 15

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ilke dolgun

CONTACT

[email protected]

+905555485632

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 9, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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