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

NCT ID: NCT06219928

Last Updated: 2024-11-18

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2023-09-15

Brief Summary

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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.

Detailed Description

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General anesthesia will apply to all patients. Group 1 (Control Group, n=15); After intubation, saline infusion will be started. The control group will also be infused with the same volume of saline.

Group 2 (Ketamine Group, n=15); After intubation, the patient will be started on ketamine infusion at a low dose of 0.25mg/kg/hour.

Group 3 (Dexmedetomidine Group, n=15); 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.

For biochemical examination, blood will be taken for PEDF (Pigment epithelium-derived factor), Pentraxin 3, Serum amyloid A at the 1st and 12th postoperative hour. AST, ALT, GGT, LDH, bilirubin, CRP and hemogram results, which are routinely checked during these hours, will be recorded.

All the patients were administered 1000 mg iv paracetamol 30 minutes before the surgery ended, and was repeated every 6 hours following the surgery.The postoperative analgesia was evaluated by using VAS(Visual Analogue Scale).The PCA (Patient Controlled Analgesia) device was programmed at 10 μcq concentration with loading dose 50 μcq, 15-minute lock time, 25 μcq bolus without basal infusion, and this was continued for 24 hours in the postoperative recovery room.

Conditions

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Inflammation Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Saline

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

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type PROCEDURE

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

Ketamine

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

Group Type ACTIVE_COMPARATOR

Ketamine Group

Intervention Type PROCEDURE

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

Dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type 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.

Interventions

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Control Group

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

Intervention Type PROCEDURE

Ketamine Group

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

Intervention Type PROCEDURE

Dexmedetomidine

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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irem ateş

Associate Professor as the Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ataturk University

Erzurum, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 23811302 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21182222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28656530 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40629656 (View on PubMed)

Other Identifiers

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B.30.2.ATA.0.01.OO/6

Identifier Type: -

Identifier Source: org_study_id

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