Liver FailurePhase 4NCT05441150
Intravenous Ketamine Infusion on Postoperative Analgesia of Living Liver Donors
A Phase 4 study testing Low dose ketamine infusion and 0.9% NaCl infusion in people with Liver Failure and Liver Transplant; Complications, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Because of the insufficiency of cadaveric organs and increasing need for organs, the interest in living donor liver transplantation have been greatly increased. The relative reduction of the remaining liver after the operation in Living Liver Donors makes it difficult and compelling to choose a very effective and very… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Failure, Liver Transplant; Complications, Post Operative Pain
- What is being tested?
- Low dose ketamine infusion and 0.9% NaCl infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Nov 2022
- Phase
- Phase 4
- 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
- living liver donors, aged 16-65 years, who are scheduled for right hepatectomy will be included in the study.
Who cannot join
- to use opioid medications before surgery,
- trauma,
- body mass index (BMI) >35,
- unstable ischemic heart disease,
- increased intracranial or intraocular pressure,
- lactation,
Show all 10Show fewer
- to have an allergic to ketamine, morphine, propofol or remifentanil,
- psychiatric illness, patient-controlled analgesia (PCA)
- unwillingness or inability to use the device
- inability to use the numerical rating scale (NRS).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Inonu university
Malatya, 044100
Mehmet A Erdogan, MD, +904223410660, drmalierdogan@gmail.com
About this study
Official title: Effect of Intraoperative Intravenous Ketamine Infusion on Postoperative Analgesia in Right Hepatectomy of Living Liver Donors
Because of the insufficiency of cadaveric organs and increasing need for organs, the interest in living donor liver transplantation have been greatly increased. The relative reduction of the remaining liver after the operation in Living Liver Donors makes it difficult and compelling to choose a very effective and very safe method in the management of postoperative analgesia.
Opioids are the main agents used in the postoperative analgesia of Live Liver Donors. Opioids have serious side effects such as respiratory depression, apnea, circulatory collapse, coma, and death. Both short-term and long-term administration of opioids cause acute opioid-induced hyperalgesia.
Read more
Ketamine, an NMDA receptor antagonist, has been hypothesized to counter opioid tolerance and NMDA receptor-mediated central sensitization. Various studies and systematic reviews have shown that low-dose ketamine has an opioid-sparing effect in all surgical patients.
Although low-dose ketamine has been shown to be beneficial overall in relieving pain, it is unclear whether it has an identified benefit in hepatectomy cases. The aim of this clinical trial was to evaluate the effect of low-dose ketamine administration on postoperative analgesia in living donor liver donors undergoing right hepatectomy procedure.
Read the detailed description
Liver transplantation is the only treatment for end-stage liver failure. The insufficiency of cadaveric organs and the inability to meet the increasing need for organs with cadaveric transplantations have greatly increased the interest in living donor liver transplantation. The relative reduction of the remaining liver after the operation in Living Liver Donors makes it difficult and compelling to choose a very effective and very safe method in the management of postoperative analgesia.
Opioids are the main agents used in the postoperative analgesia of Live Liver Donors. Opioids have serious side effects such as respiratory depression, apnea, circulatory collapse, coma, and death. Both short-term and long-term administration of opioids cause acute opioid-induced hyperalgesia.
There is evidence that opioid tolerance can occur in the dorsal root ganglion through N-methyl-D-aspartate (NMDA) receptor activation. Ketamine, an NMDA receptor antagonist, has been hypothesized to counter opioid tolerance and NMDA receptor-mediated central sensitization. Low-dose ketamine is an effective adjuvant in painful orthopedic procedures that reduces pain and opioid need, especially in the first 24 hours after the procedure. Various studies and systematic reviews have shown that low-dose ketamine has an opioid-sparing effect in all surgical patients.
Although low-dose ketamine has been shown to be beneficial overall in relieving pain, it is unclear whether it has an identified benefit in hepatectomy cases. The aim of this randomized placebo-controlled clinical trial was to evaluate the effect of low-dose ketamine administration on postoperative analgesia in living donor liver donors undergoing a painful right hepatectomy procedure.
- Being tested
- Low dose ketamine infusion, 0.9% NaCl infusion
- Keywords
- Living liver donor, Liver, Transplantation, postoperative pain, ketamine
- Medical subject headings
- Liver Failure, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose ketamine infusionDrug
Also called Ketamine
Administering low-dose ketamine infusion to the patient under general anesthesia for Ketamine Group.
0.9% NaCl infusionDrug
Also called Saline
Same dose of 0.9% NaCl infusion as the dose of ketamine for Control Group.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Group | Active comparator | Patients who received low-dose ketamine infusion Receives: Drug: Low dose ketamine infusion |
| Control group | Sham comparator | Patients who received 0.9% Sodium Chloride Solution, Intravenous, (NaCl) infusion Receives: Drug: 0.9% NaCl infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
To determine the cumulative opioid consumption at the end of 24 hours in patients who received low-dose ketamine or 0.9% NaCl infusion.
Measured: 24 hour
Secondary outcomes (2)
Postop Sedation Score
Postop Sedation Score (0-3): sedation was measured on a scale of 0 to 3 0: fully awake; 1: lightly sedated, rarely sleepy and easily aroused; 2: moderately sedated, often sleepy and easily aroused; 3; severely sedated, sleepy and difficult to wake up
Measured: Postoperative 1 hour
postoperative complications
postoperative complications: pruritus, vomiting, hallucination
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Jun 2022
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- More trials run by Inonu 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ali Erdoğan, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441150
- Sponsor's protocol ID
- Ketamin-Postopanalgesia
- Status last verified
- Jul 2022
- First submitted
- 28 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I am hesitant to share the data before completing the study. However after end of the study I might consider sharing
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Intravenous Ketamine Infusion on Postoperative Analgesia in Right Hepatectomy of Living Liver Donors
- ClinicalTrials.gov ID
- NCT05441150
- Acronym / sponsor ID
- Ketamin-Postopanalgesia
- Keywords
- Living liver donor, Liver, Transplantation, postoperative pain, ketamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 1 Jul 2022 (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.
Because of the insufficiency of cadaveric organs and increasing need for organs, the interest in living donor liver transplantation have been greatly increased. The relative reduction of the remaining liver after the operation in Living Liver Donors makes it difficult and compelling to choose a very effective and very safe method in the management of postoperative analgesia.
Opioids are the main agents used in the postoperative analgesia of Live Liver Donors. Opioids have serious side effects such as respiratory depression, apnea, circulatory collapse, coma, and death. Both short-term and long-term administration of opioids cause acute opioid-induced hyperalgesia.
Ketamine, an NMDA receptor antagonist, has been hypothesized to counter opioid tolerance and NMDA receptor-mediated central sensitization. Various studies and systematic reviews have shown that low-dose ketamine has an opioid-sparing effect in all surgical patients.
Although low-dose ketamine has been shown to be beneficial overall in relieving pain, it is unclear whether it has an identified benefit in hepatectomy cases. The aim of this clinical trial was to evaluate the effect of low-dose ketamine administration on postoperative analgesia in living donor liver donors undergoing right hepatectomy procedure.
Detailed description
Liver transplantation is the only treatment for end-stage liver failure. The insufficiency of cadaveric organs and the inability to meet the increasing need for organs with cadaveric transplantations have greatly increased the interest in living donor liver transplantation. The relative reduction of the remaining liver after the operation in Living Liver Donors makes it difficult and compelling to choose a very effective and very safe method in the management of postoperative analgesia.
Opioids are the main agents used in the postoperative analgesia of Live Liver Donors. Opioids have serious side effects such as respiratory depression, apnea, circulatory collapse, coma, and death. Both short-term and long-term administration of opioids cause acute opioid-induced hyperalgesia.
There is evidence that opioid tolerance can occur in the dorsal root ganglion through N-methyl-D-aspartate (NMDA) receptor activation. Ketamine, an NMDA receptor antagonist, has been hypothesized to counter opioid tolerance and NMDA receptor-mediated central sensitization. Low-dose ketamine is an effective adjuvant in painful orthopedic procedures that reduces pain and opioid need, especially in the first 24 hours after the procedure. Various studies and systematic reviews have shown that low-dose ketamine has an opioid-sparing effect in all surgical patients.
Although low-dose ketamine has been shown to be beneficial overall in relieving pain, it is unclear whether it has an identified benefit in hepatectomy cases. The aim of this randomized placebo-controlled clinical trial was to evaluate the effect of low-dose ketamine administration on postoperative analgesia in living donor liver donors undergoing a painful right hepatectomy procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Group | Active comparator | Drug: Low dose ketamine infusionPatients who received low-dose ketamine infusion |
| Control group | Sham comparator | Drug: 0.9% NaCl infusionPatients who received 0.9% Sodium Chloride Solution, Intravenous, (NaCl) infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- living liver donors, aged 16-65 years, who are scheduled for right hepatectomy will be included in the study.
Key exclusion criteria (10 listed)
- to use opioid medications before surgery,
- trauma,
- body mass index (BMI) >35,
- unstable ischemic heart disease,
- increased intracranial or intraocular pressure,
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 |
|---|---|---|
| Low dose ketamine infusionAlso: KetamineAdministering low-dose ketamine infusion to the patient under general anesthesia for Ketamine Group. | Drug | Ketamine Group |
| 0.9% NaCl infusionAlso: SalineSame dose of 0.9% NaCl infusion as the dose of ketamine for Control Group. | Drug | Control group |
Primary outcome
Postoperative opioid consumption
Time frame: 24 hour
To determine the cumulative opioid consumption at the end of 24 hours in patients who received low-dose ketamine or 0.9% NaCl infusion.
2 secondary outcomes
Postop Sedation Score
Time frame: Postoperative 1 hour
postoperative complications
Time frame: 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Individual participant dataSharing planned: Undecided. I am hesitant to share the data before completing the study. However after end of the study I might consider sharing
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low dose ketamine infusion and 0.9% NaCl infusion in people with Liver Failure and Liver Transplant; Complications, run by Inonu 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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 5 Jul 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nucin Gulhas, Prof. (+90 4223410660 ext. 3121, nurcin.gulhas@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid consumption (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2022.