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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06219928
Enrollment
45
Registered
2024-01-23
Start date
2022-06-30
Completion date
2023-09-15
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Analgesia

Keywords

Liver resection, ketamine, dexmedetomidine, inflammation

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.

Detailed 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.

Interventions

PROCEDUREControl Group

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

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

PROCEDUREDexmedetomidine

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.

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Level of Pentraxin in ng/mLAfter the OperationPentraxin 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.
Serum Amyloid A level in mcg/mlAfter the operationSerum 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026