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临床试验/NCT04908345
NCT04908345Unknown3 期

Intraoperative Use Of Methadone In The Prevention of Postoperative Pain in Kidney Transplant Receptors

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年5月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
32
试验地点
1
主要终点
Pain score 24h postoperatively

研究概览

简要总结

Intraoperative methadone or fentanyl will be administered to patients submitted to kidney transplant surgery. Postoperative pain, analgesic consumption and side effects will be evaluated

详细描述

Despite recent developments in postoperative pain control, many patients still experience moderate or severe pain after surgery. It is estimated that severe postoperative pain occurs in 20 to 40% of surgical procedures. With the development of kidney transplant services, a better study of the intraoperative analgesia used in this procedure and its impact on the postoperative is necessary. The management of postoperative pain in renal transplant recipients is essential to improve the quality of postoperative care, and may even impact the prognosis of the renal graft. One of the strategies to improve pain control in the perioperative period is the intraoperative use of intravenous methadone, given its pharmacokinetic profile. Methadone is an opioid agonist of µ receptors, it is also a Glutamate antagonist by blocking the N-methyl-D-aspartate (NMDA) receptor, and inhibits the reuptake of serotonin and norepinephrine. When administered in doses of 20 to 30mg, the analgesia generated by methadone can last from 24 to 36 hours. There is also evidence that the use of methadone in doses of 0.2 to 0.3 mg / kg is not associated with a higher incidence of side effects when compared to other opioids with short or intermediate duration of action, such as fentanyl, sufentanil and morphine. The aim of this study is to evaluate the effectiveness of using intraoperative methadone to reduce postoperative pain in patients undergoing kidney transplant surgery (recipients). Patients will be submitted to standardized general anesthesia, and the opioid used in anesthetic induction will be methadone or fentanyl with additional boluses if necessary. After extubation, Fentanyl will be installed in an intravenous analgesia pump controlled by the patient. Differences between groups regarding opioid consumption, pain scores, side effects and patient satisfaction will be assessed

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients over 18 years of age
  • With indication for kidney transplant surgery
  • Who sign the informed consent form

排除标准

  • Patients who refuse to participate in the study
  • Known allergy to any drug used in this protocol
  • Presence of stage III or IV congestive heart failure
  • Increase in QT interval on electrocardiogram (QT> 500 msec)
  • Preemptive kidney transplantation (defined by transplantation in a patient who has not yet started kidney replacement therapy).

研究组 & 干预措施

Methadone

Experimental

Methadone 0,075mg/kg for induction and half of induction dose of boluses as needed during surgery

干预措施: Methadone (Drug)

Fentanyl

Active Comparator

Fentanyl 3 mcg/kg for induction and half of induction dose of boluses as needed during surgery

干预措施: Fentanyl (Drug)

结局指标

主要结局

Pain score 24h postoperatively

时间窗: One day after surgery

Reported pain in a scale of 0 (no pain) to 10 (maximum pain)

Pain score 72h postoperatively

时间窗: Three days after surgery

Reported pain in a scale of 0 (no pain) to 10 (maximum pain)

Analgesic use 24h postoperatively

时间窗: One day after surgery

Analgesic use after surgery

Analgesic use 48h postoperatively

时间窗: Two days after surgery

Analgesic use after surgery

Pain score 48h postoperatively

时间窗: Two days after surgery

Reported pain in a scale of 0 (no pain) to 10 (maximum pain)

Analgesic use 72h postoperatively

时间窗: Three days after surgery

Analgesic use after surgery

次要结局

  • Opioid-related side effects 24h postoperatively(One day after surgery)
  • Opioid-related side effects 48h postoperatively(Two days after surgery)
  • Opioid-related side effects 72h postoperatively(Three days after surgery)

研究者

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

Felipe Chiodini Machado

Principal Investigator

University of Sao Paulo General Hospital

研究点 (1)

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