Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)
NCT Number: NCT06963294
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.
Trial opening soon.
Get Notified18 year–100 year
All sexes
Interventional
Not applicable
Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ketamine will be administered as an intravenous infusion at 0.1 mg/kg/hour during surgery
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.
Contact information is provided by the study sponsor or research team.
Istinye University
Other
The Effect of Intraoperative Ketamine and Dexmedetomidine Use on Postoperative Delirium and Cognitive Dysfunction in Patients Undergoing Total Joint Arthroplasty
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.
Published trials that share one or more normalized conditions with this study.
NCT07192549
Cognition Disorders, Cognitive Dysfunction
View Trial DetailsNCT07719712
Cognition Disorders, Cognitive Dysfunction
Muğla, Turkey (Türkiye)
View Trial DetailsNCT05574400
Alzheimer Disease, Brain Diseases
Ann Arbor, Michigan, United States
View Trial DetailsNCT05595954
Cardiovascular Diseases, Cognition Disorders
Basel, Switzerland
View Trial Details