InflammationNCT06219928
Comparison of the Effects of Dexmedetomidine and Ketamine Infusion on the Inflammatory Response in Liver Resection
A study testing Ketamine Group and Dexmedetomidine in people with Inflammation and Analgesia, run by Ataturk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Analgesia
- What is being tested?
- Ketamine Group and Dexmedetomidine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2022to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Dexmedetomidine and Ketamine Infusion on the Inflammatory Response in Liver Resection: a Randomized Double-blind Placebo Study
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.
Read the 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.
- Conditions
- Inflammation, Analgesia
- Being tested
- Control Group, Ketamine Group, Dexmedetomidine
- Keywords
- Liver resection, ketamine, dexmedetomidine, inflammation
- Medical subject headings
- Inflammation, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupProcedure or surgery
After intubation, saline infusion will be started. The control group will also be infused with the same volume of saline
Ketamine GroupProcedure or surgery
After intubation, the patient will be started on ketamine infusion at a low dose of 0.25mg/kg/hour.
DexmedetomidineProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Saline | Active comparator | After intubation, saline infusion will be started. The control group will also be infused with the same volume of saline.. Receives: 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. Receives: 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 Receives: Procedure: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start30 Jun 2022
- Primary completion30 Jun 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, irem ateş, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219928
- Sponsor's protocol ID
- B.30.2.ATA.0.01.OO/6
- Status last verified
- Nov 2024
- First submitted
- 3 Jan 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23811302Siriussawakul 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.
PubMed 21182222Ando 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.
PubMed 28656530Ates 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.
PubMed 40629656
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Dexmedetomidine and Ketamine Infusion on the Inflammatory Response in Liver Resection: a Randomized Double-blind Placebo Study
- ClinicalTrials.gov ID
- NCT06219928
- Acronym / sponsor ID
- B.30.2.ATA.0.01.OO/6
- Conditions
- Inflammation, Analgesia
- Keywords
- Liver resection, ketamine, dexmedetomidine, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saline | Active comparator | Procedure: Control GroupAfter intubation, saline infusion will be started. The control group will also be infused with the same volume of saline.. |
| Ketamine | Active comparator | Procedure: Ketamine GroupAfter intubation, the patient will be started on ketamine infusion at a low dose of 0.25mg/kg/hour. |
| Dexmedetomidine | Active comparator | Procedure: DexmedetomidineAfter 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control GroupAfter intubation, saline infusion will be started. The control group will also be infused with the same volume of saline | Procedure or surgery | Saline |
| Ketamine GroupAfter intubation, the patient will be started on ketamine infusion at a low dose of 0.25mg/kg/hour. | Procedure or surgery | Ketamine |
| DexmedetomidineAfter 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. | Procedure or surgery | Dexmedetomidine |
Primary outcome
Level of Pentraxin in ng/mL
Time frame: After the Operation
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.
Serum Amyloid A level in mcg/ml
Time frame: After the operation
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Background: PubMed 23811302Peralta 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.
- Background: PubMed 21182222Siriussawakul 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.
- Background: PubMed 28656530Ando 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.
- Derived from this study: PubMed 40629656Ates 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine Group and Dexmedetomidine in people with Inflammation and Analgesia, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Pentraxin in ng/mL (time frame: After the Operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06219928, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.