Ketamine and Dexmedetomidine for Delirium in Joint Arthroplasty

Not Applicable

Not yet recruiting

• Conditions: Postoperative Delirium; Postoperative Cognitive Dysfunction
• Interventions: Drug: Ketamine

• Registration Number: NCT06963294
• Lead Sponsor: Istinye University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-30
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study First Posted: 2025-05-09
• Last Update Posted: 2025-05-09
• Study Start: 2026-05-05
• Primary Completion: 2026-06-15
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline Infusion	Ketamine	Participants receive 0.9% saline at 30 mL/hour during surgery.
Ketamine Infusion	Ketamine	Participants receive ketamine at 0.1 mg/kg/hour as intraoperative infusion
Dexmedetomidine Infusion	Ketamine	Participants receive dexmedetomidine at 0.5 mcg/kg/hour as intraoperative infusion
Ketamine + Dexmedetomidine	Ketamine	Participants receive a combination of ketamine (0.3 mg/kg/hour) and dexmedetomidine (0.5 mcg/kg/hour) as intraoperative infusion.

Primary Outcome Measures

Name	Time	Method
Incidence of Postoperative Cognitive Dysfunction (POCD) Measured by MMSE	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.

Trial Locations

Locations (1)

Istinye Üniversity; 🇹🇷 Istanbul, Merkez Mahallesi, Turkey