Clinical Research Directory

Investigation of the Anti-inflammatory Effect of Ketamine in Cardiac Surgery

Sponsor: Konya City Hospital

Summary

Background: Cardiac surgery with cardiopulmonary bypass induces a systemic inflammatory response that may contribute to postoperative complications. Ketamine has been investigated for its potential immunomodulatory effects. This randomised controlled trial evaluated the effects of intraoperative ketamine administration on postoperative inflammatory biomarkers and clinical outcomes in patients undergoing elective cardiac surgery. Methods: This single-centre, randomised, controlled, single-blind trial was conducted at Necmettin Erbakan University Meram Faculty of Medicine Hospital, Türkiye. Between 30 October 2022 and 30 March 2023, 177 patients were assessed for eligibility, of whom 166 provided written informed consent and were randomised to the ketamine (n = 83) or control (n = 83) group. All patients received standard general anaesthesia. In addition, the ketamine group received an intravenous ketamine bolus of 1 mg/kg at induction, followed by a continuous intraoperative infusion of 2.4 mg/kg/h. The two primary outcomes specified in the original study protocol dated 5 September 2022 were neutrophil-to-lymphocyte ratio (NLR) and C-reactive protein (CRP), measured on postoperative day 1. The prespecified secondary outcomes included postoperative pain intensity assessed using the Numeric Rating Scale (NRS) and Prince Henry Hospital Pain Score (PHHPS), time to extubation, intensive care unit length of stay, and hospital length of stay. Additional inflammatory parameters, including platelet-to-lymphocyte ratio (PLR), systemic inflammatory response index (SIRI), systemic immune-inflammation index (SII), and derived measures of perioperative biomarker changes, were evaluated in post hoc exploratory analyses. Additional clinical outcomes, including 28-day all-cause mortality, were also assessed on an exploratory basis. Six randomised patients (three per group) died before postoperative day 1 biomarker measurements could be obtained. Consequently, 160 patients (80 per group) were included in the primary biomarker analyses, while all 166 randomised patients were included in the 28-day mortality analysis. The study was retrospectively registered at ClinicalTrials.gov on 30 March 2026, after completion of recruitment and data collection.

Official title: Investigation of the Anti-inflammatory Effect of Ketamine in Cardiac Surgery : Randomızed Controlled Trıal

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