Ketamine and Dexmedetomidine for Delirium in Joint Arthroplasty

NCT06963294 | Not Yet Recruiting

• 1 other identifier: Haseki berna
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium; Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (preoperative), Postoperative Day 2, and Postoperative Day 15

Study Arms (4)

Saline Infusion

PLACEBO COMPARATOR

Participants receive 0.9% saline at 30 mL/hour during surgery.

Drug: Ketamine

Ketamine Infusion

EXPERIMENTAL

Participants receive ketamine at 0.1 mg/kg/hour as intraoperative infusion

Drug: Ketamine

Dexmedetomidine Infusion

EXPERIMENTAL

Participants receive dexmedetomidine at 0.5 mcg/kg/hour as intraoperative infusion

Drug: Ketamine

Ketamine + Dexmedetomidine

EXPERIMENTAL

Participants receive a combination of ketamine (0.3 mg/kg/hour) and dexmedetomidine (0.5 mcg/kg/hour) as intraoperative infusion.

Drug: Ketamine

Interventions

Ketamine DRUG

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

Dexmedetomidine Infusion; Ketamine + Dexmedetomidine; Ketamine Infusion; Saline Infusion

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 29947091 RESULT

• 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.

  PMID: 35543164 RESULT

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

ilke dolgun

CONTACT

+905555485632; ilkeser2004@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 9, 2025
• Study Start: May 5, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)