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

NCT07536633 | Completed Phase 4

• 1 other identifier: 2022/926
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The inflammatory response following cardiac surgery is known to contribute significantly to morbidity and mortality. Neutrophils and inflammatory mediators play a critical role in the pathogenesis of postoperative complications. The aim of this study was to evaluate the effect of intraoperative ketamine administration on the inflammatory response in patients undergoing cardiac surgery using routinely employed immuno-inflammatory parameters in clinical practice. Methods: After randomization, patients were divided into two groups: the ketamine group and the control group. Following admission to the operating room, standard monitoring and anesthesia induction were performed. In addition to the control group, patients in the ketamine group received 1 mg/kg ketamine during induction and a continuous intravenous infusion of 2.4 mg/kg/h ketamine for maintenance. Immuno-inflammatory parameters were assessed using routine blood tests obtained preoperatively and on postoperative day 1. These parameters included leukocyte, neutrophil, lymphocyte, and platelet counts; neutrophil-to-lymphocyte ratio (NLR); platelet-to-lymphocyte ratio (PLR); NLR index; delta NLR; ΔPLR; PLR index; systemic inflammatory response index (SIRI); systemic immune-inflammation index (SII); and C-reactive protein (CRP), ΔCRP, and CRP index. In addition, patients' pain scores within the first 24 hours following postoperative extubation, as well as hospital mortality and morbidity rates, were evaluated.

Conditions

Cardiac Surgery

Keywords

Ketamine; Cardiac Surgery; Inflammatory response

Outcome Measures

Primary Outcomes (14)

• Change in Neutrophil-to-Lymphocyte Ratio (NLR)

  Neutrophil-to-lymphocyte ratio (NLR), expressed as a dimensionless ratio, calculated as neutrophil count divided by lymphocyte count, evaluated as postoperative minus preoperative values.

  Preoperative to postoperative day 1 (within 24 hours)

• Systemic Immune-Inflammation Index (SII)

  Systemic Immune-Inflammation Index (SII), expressed as an index value, calculated as platelet count × neutrophil count divided by lymphocyte count.

  Preoperative and postoperative day 1

• Systemic Inflammatory Response Index (SIRI)

  Systemic Inflammatory Response Index (SIRI), expressed as an index value, calculated as neutrophil count × monocyte count divided by lymphocyte count.

  Preoperative and postoperative day 1

• Change in Platelet-to-Lymphocyte Ratio (PLR)

  Platelet-to-lymphocyte ratio (PLR), expressed as a dimensionless ratio, calculated as platelet count divided by lymphocyte count, evaluated as postoperative minus preoperative values.

  Preoperative to postoperative day 1

• Change in C-Reactive Protein (CRP)

  Serum C-reactive protein (CRP) levels measured in mg/L, assessed preoperatively and on postoperative day 1, expressed as postoperative minus preoperative values.

  Preoperative to postoperative day 1 (within 24 hours)

• Change in Neutrophil Count

  Neutrophil count measured in 10³/µL, assessed preoperatively and on postoperative day 1, expressed as the change between measurements.

  Preoperative to postoperative day 1 (within 24 hours)

• Change in Lymphocyte Count

  Lymphocyte count measured in 10³/µL, assessed preoperatively and on postoperative day 1.

  Preoperative to postoperative day 1 (within 24 hours)

• Change in Platelet Count

  Platelet count measured in 10³/µL, assessed preoperatively and on postoperative day 1.

  Preoperative to postoperative day 1 (within 24 hours)

• NLR Index

  NLR index calculated as postoperative NLR divided by preoperative NLR, expressed as a ratio.

  Postoperative day 1

• PLR Index

  PLR index calculated as postoperative PLR divided by preoperative PLR, expressed as a ratio.

  Postoperative day 1

• CRP Index

  CRP index calculated as postoperative CRP divided by preoperative CRP.

  Postoperative day 1

• Delta NLR

  Delta NLR calculated as postoperative NLR minus preoperative NLR.

  Postoperative day 1

• Delta PLR

  Delta PLR calculated as postoperative PLR minus preoperative PLR.

  Postoperative day 1

• Delta CRP

  Delta CRP calculated as postoperative CRP minus preoperative CRP.

  Postoperative day 1

Secondary Outcomes (8)

• Extubation Time

  From the end of surgery to tracheal extubation, within 48 hours postoperatively

• Length of ICU Stay

  From ICU admission to ICU discharge (up to 28 days)

• Length of Hospital Stay

  From the date of surgery to hospital discharge (up to 28 days)

• Postoperative Pain Score (NRS)

  First 24 hours after extubation

• 28-day Mortality

  28 days postoperative

Study Arms (2)

control group

NO INTERVENTION

Standard treatment was administered to all patients.

ketamine group

ACTIVE COMPARATOR

In addition to standard treatment, ketamine was administered at a dose of 1 mg/kg during induction and as a continuous infusion at 2.4 mg/kg/h

Drug: ketamine

Interventions

ketamine DRUG

In addition to standard treatment, ketamine was administered at a dose of 1 mg/kg during induction and as a continuous infusion at 2.4 mg/kg/h

Also known as: Ketamine hydrochloride, Ketalar

ketamine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 years.
• Scheduled to undergo elective cardiac surgery.
• Able to provide informed consent.

You may not qualify if:

• Contraindications to anesthesia.
• Cognitive impairment or communication barriers.
• End-stage renal failure (receiving routine hemodialysis).
• Pregnancy or breastfeeding.
• Known allergy to ketamine.
• Ejection fraction (EF) \<35%.
• Emergency or repeat surgery.
• Arrhythmia.
• Morbid obesity.
• Psychiatric disorders.
• Hepatic failure.
• Use of anti-inflammatory medications.
• Preoperative white blood cell count (leukocyte) ≥15 × 10³/µL.
• C-reactive protein (CRP) ≥30 mg/L.
• Declined to participate in the study

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Necmettin Erbakan University Meram Faculty of Medicine Hospital

Meram, Konya, 42000, Turkey (Türkiye)

Location

Related Publications (1)

• Welters ID, Feurer MK, Preiss V, Muller M, Scholz S, Kwapisz M, Mogk M, Neuhauser C. Continuous S-(+)-ketamine administration during elective coronary artery bypass graft surgery attenuates pro-inflammatory cytokine response during and after cardiopulmonary bypass. Br J Anaesth. 2011 Feb;106(2):172-9. doi: 10.1093/bja/aeq341. Epub 2010 Dec 7.

  PMID: 21138901 BACKGROUND

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Turgay Atay

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

• gamze sarkılar

  Necmettin Erbakan University Meram Faculty of Medicine Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator-medical doctor

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 17, 2026
• Study Start: October 30, 2022
• Primary Completion: March 30, 2023
• Study Completion: May 30, 2023
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting March 2026 and available upon reasonable request
• Access Criteria: De-identified individual participant data will be available upon reasonable request from the corresponding author (turgayatay@gmail.com). Requests will be evaluated based on scientific merit and ethical considerations. Data will be shared after approval of a research proposal and signing of a data use agreement.

Locations

TU (1)