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

Inflammation Clinical Trial

Official title:

Comparison of the Effects of Dexmedetomidine and Ketamine Infusion on the Inflammatory Response in Liver Resection: A Randomized Double-blind Placebo Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06219928
• Other study ID #: B.30.2.ATA.0.01.OO/6
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Inflammation

Intervention

Procedure:
• Control Group
After intubation, saline infusion will be started. The control group will also be infused with the same volume of saline
• Ketamine Group
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 for the first 10 minutes, then 0.5 mg/kg/hour.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation damage	The study will involve the evaluation of inflammation damage in the liver tissue left behind during liver resection was evaluated	During the operation
Primary	Level of Pigment epithelium-derived factor (PEDF)	Pigment epithelium-derived factor level will be measured with Enzyme-Linked ImmunoSorbent Assay technique after the liver resection (it is a unitless variable)	During the operation
Primary	Level of Pentraxin	Pentraxin levels will be measured in terms ng/mL with Enzyme-Linked ImmunoSorbent Assay technique after the liver resection	During the operation
Primary	Serum Amyloid A level	Serum Amyloid A level will be measured in terms of mcg/ml with Enzyme-Linked ImmunoSorbent Assay technique after the liver resection	During the operation