Ketamine and Dexmedetomidine for Delirium in Joint Arthroplasty
NCT ID: NCT06963294
Last Updated: 2025-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2026-05-05
2026-07-15
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Saline Infusion
Participants receive 0.9% saline at 30 mL/hour during surgery.
Ketamine
Ketamine will be administered as an intravenous infusion at 0.1 mg/kg/hour during surgery
Ketamine Infusion
Participants receive ketamine at 0.1 mg/kg/hour as intraoperative infusion
Ketamine
Ketamine will be administered as an intravenous infusion at 0.1 mg/kg/hour during surgery
Dexmedetomidine Infusion
Participants receive dexmedetomidine at 0.5 mcg/kg/hour as intraoperative infusion
Ketamine
Ketamine will be administered as an intravenous infusion at 0.1 mg/kg/hour during surgery
Ketamine + Dexmedetomidine
Participants receive a combination of ketamine (0.3 mg/kg/hour) and dexmedetomidine (0.5 mcg/kg/hour) as intraoperative infusion.
Ketamine
Ketamine will be administered as an intravenous infusion at 0.1 mg/kg/hour during surgery
Interventions
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Ketamine
Ketamine will be administered as an intravenous infusion at 0.1 mg/kg/hour during surgery
Eligibility Criteria
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Inclusion Criteria
* ASA physical status I-III
* Age between 18 and 100 years
* Ability to provide informed consent and comply with cognitive assessments
Exclusion Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
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Istinye University
OTHER
Responsible Party
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İlke Dolgun
Assoc. prof
Locations
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Istinye Üniversity
Istanbul, Merkez Mahallesi, Turkey (Türkiye)
Countries
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Central Contacts
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References
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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.
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.
Other Identifiers
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Haseki berna
Identifier Type: -
Identifier Source: org_study_id
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