Comparison of the Effects of Dexmedetomidine and Ketamine Infusion on the Inflammatory Response in Liver Resection

NCT06219928 | Completed

• 1 other identifier: B.30.2.ATA.0.01.OO/6
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Resection is being performed with increasing frequency in the treatment of surgical diseases of the liver. Ischemia-reperfusion injury is a major cause of liver injury occurring during surgical procedures, including hepatic resection and liver transplantation. Dexmedetomidine and ketamine, which are frequently used in anesthesia practice, also have strong anti-inflammatory capacity. The primary aim of this study is to investigate the effect of iv low-dose ketamine and dexmedetomidine infusion on inflammation in liver resection surgery, and the secondary aim is to determine its effect on pain scores.

Conditions

Inflammation; Analgesia

Keywords

Liver resection; ketamine; dexmedetomidine; inflammation

Outcome Measures

Primary Outcomes (2)

• Level of Pentraxin in ng/mL

  Pentraxin levels of the patients in both groups will be measured in terms ng/mL with Enzyme-Linked ImmunoSorbent Assay technique after the liver resection postoperatively.

  After the Operation

• Serum Amyloid A level in mcg/ml

  Serum Amyloid A level of all patients in both groups will be measured in terms of mcg/ml with Enzyme-Linked ImmunoSorbent Assay technique after the liver resection postoperatively.

  After the operation

Study Arms (3)

Saline

ACTIVE COMPARATOR

After intubation, saline infusion will be started. The control group will also be infused with the same volume of saline..

Procedure: Control Group

Ketamine

ACTIVE COMPARATOR

After intubation, the patient will be started on ketamine infusion at a low dose of 0.25mg/kg/hour.

Procedure: Ketamine Group

Dexmedetomidine

ACTIVE COMPARATOR

After intubation, the patient will be infused at a low dose of 1 mg/kg dexmedetomidine for the first 10 minutes, then 0.5 mg/kg/hour

Procedure: Dexmedetomidine

Interventions

Control Group PROCEDURE

After intubation, saline infusion will be started. The control group will also be infused with the same volume of saline

Saline

Ketamine Group PROCEDURE

After intubation, the patient will be started on ketamine infusion at a low dose of 0.25mg/kg/hour.

Ketamine

Dexmedetomidine PROCEDURE

After intubation, the patient will be infused at a low dose of 1 mg/kg for the first 10 minutes, then 0.5 mg/kg/hour.

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA (American Society of Anaesthesiologists) I-II-III group who will undergo liver resection surgery,
• no known history of heart, kidney, hematological disease, peptic ulcer, gastrointestinal bleeding, allergy, chronic pain
• who agreed to participate in the study

You may not qualify if:

• Patients with underlying serious cardiovascular disease,
• patients who cannot cooperate, patients who are allergic to one of the drugs to be used
• patients who do not want to participate

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Related Publications (4)

• Peralta C, Jimenez-Castro MB, Gracia-Sancho J. Hepatic ischemia and reperfusion injury: effects on the liver sinusoidal milieu. J Hepatol. 2013 Nov;59(5):1094-106. doi: 10.1016/j.jhep.2013.06.017. Epub 2013 Jun 25.

  PMID: 23811302 BACKGROUND

• Siriussawakul A, Zaky A, Lang JD. Role of nitric oxide in hepatic ischemia-reperfusion injury. World J Gastroenterol. 2010 Dec 28;16(48):6079-86. doi: 10.3748/wjg.v16.i48.6079.

  PMID: 21182222 BACKGROUND

• Ando T, Ito H, Kanbe A, Hara A, Seishima M. Deficiency of NALP3 Signaling Impairs Liver Regeneration After Partial Hepatectomy. Inflammation. 2017 Oct;40(5):1717-1725. doi: 10.1007/s10753-017-0613-6.

  PMID: 28656530 BACKGROUND

• Ates I, Laloglu E, Kara S, Yaman T, Isik B. The effects of dexmedetomidine and ketamine infusions on the inflammatory response in liver resection: A randomized double-blind placebo study. Medicine (Baltimore). 2025 Jul 4;104(27):e42999. doi: 10.1097/MD.0000000000042999.

  PMID: 40629656 DERIVED

MeSH Terms

Conditions

Inflammation; Agnosia

Interventions

Control Groups; Dexmedetomidine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor as the Principal Investigator

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 23, 2024
• Study Start: June 30, 2022
• Primary Completion: June 30, 2023
• Study Completion: September 15, 2023
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)