Clinical trial NCT06963294: Ketamine and Dexmedetomidine for Delirium in Joint Arthroplasty
Official title: The Effect of Intraoperative Ketamine and Dexmedetomidine Use on Postoperative Delirium and Cognitive Dysfunction in Patients Undergoing Total Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Delirium
Postoperative Cognitive Dysfunction
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Postoperative Cognitive Dysfunction (POCD) Measured by MMSE
timeFrame: Baseline (preoperative), Postoperative Day 2, and Postoperative Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye Üniversity
state: Merkez Mahallesi
Study officials:
References:
citation: Hovaguimian F, Tschopp C, Beck-Schimmer B, Puhan M. Intraoperative ketamine administration to prevent delirium or postoperative cognitive dysfunction: A systematic review and meta-analysis. Acta Anaesthesiol Scand. 2018 Oct;62(9):1182-1193. doi: 10.1111/aas.13168. Epub 2018 Jun 26.
citation: Singh A, Brenna CTA, Broad J, Kaustov L, Choi S. The Effects of Dexmedetomidine on Perioperative Neurocognitive Outcomes After Cardiac Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Ann Surg. 2022 May 1;275(5):864-871. doi: 10.1097/SLA.0000000000005196. Epub 2021 Aug 27.