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临床试验/NCT05441150
NCT05441150Unknown4 期

Effect of Intraoperative Intravenous Ketamine Infusion on Postoperative Analgesia in Right Hepatectomy of Living Liver Donors

Inonu University1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2022年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
2
试验地点
1
主要终点
Postoperative opioid consumption

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • living liver donors, aged 16-65 years, who are scheduled for right hepatectomy will be included in the study.

排除标准

  • to use opioid medications before surgery,
  • body mass index (BMI) >35,
  • unstable ischemic heart disease,
  • increased intracranial or intraocular pressure,
  • lactation,
  • 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).

研究组 & 干预措施

Ketamine Group

Active Comparator

Patients who received low-dose ketamine infusion

干预措施: Low dose ketamine infusion (Drug)

Control group

Sham Comparator

Patients who received 0.9% Sodium Chloride Solution, Intravenous, (NaCl) infusion

干预措施: 0.9% NaCl infusion (Drug)

结局指标

主要结局

Postoperative opioid consumption

时间窗: 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.

次要结局

  • Postop Sedation Score(Postoperative 1 hour)
  • postoperative complications(24 hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Ali Erdoğan

Inonu University, School of Medicine, Department of Anaesthesiology and ReanimationMalatya, Turkey

Inonu University

研究点 (1)

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