跳至主要内容
临床试验/NCT06015711
NCT06015711招募中不适用

The Effect of Preoperative Maxigesic® Administration on Analgesic Nociception Index (ANI) Guided Remifentanil Administration

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年8月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
96
试验地点
1
主要终点
Remifentanil requirement

研究概览

简要总结

Maxigesic is combined intravenous analgesic of ibuprofen and acetaminphen. The purpose of this study is investigate weather preoperative Maxigesic administration can reduce intraoperative remifentanil requirement.

详细描述

Remifentanil is an ultra-short-acting opioid that is useful during surgery because of its fast onset and recovery. However, because of this profile, it is known that the use of high doses of remifentanil during surgery paradoxically increases postoperative pain. It has been reported that intraoperative remifentanil use resulted in higher pain scores 2 hours after surgery compared to intraoperative dexmedetomidine, and that the incidence of hypotension, tremor, and postoperative nausea and vomiting were higher in the remifentanil group. Therefore, minimizing the use of remifentanil during surgery is clinically meaningful.

Nonsteroidal anti-inflammatory drugs (NSAIDs) play an important role in multimodal analgesia, and are known to reduce the use of opioids when used together with opioids in postoperative pain [3]. It has also been reported that preoperative administration of ibuprofen reduces postoperative opioid use. Administration of acetaminophen has also been reported to reduce opioid usage. However, there is no study on whether the administration of these NSAIDs and acetaminophen reduces the opioid requirement used during surgery, not after surgery.

The Analgesia nociception index (ANI, MDoloris medical system, France) was developed to measure real-time nociception in patients undergoing surgery under general anesthesia. This index measures parasympathetic nerve activity based on heart rate variability. It is known to be superior in detecting nociceptive stimuli rather than judging only by existing pulse rate and blood pressure. In addition, since information is provided as an objectified numerical value, analgesic drugs can be adjusted during surgery based on this information. This helps to provide an appropriate amount of opioids during surgery when needed, and can prevent overdose. A previous study reported that when ANI-guided remifentanil infusion was performed, the amount of remifentanil used was reduced compared to conventional control of remifentanil only with blood pressure and pulse rate.

Maxigesic® is a combination of acetaminophen and ibuprofen, and is a drug that rapidly relieves various types of pain. It is known to be more effective in relieving postoperative pain than single acetaminophen or ibuprofen. The hypothesis of this study is that administration of Maxigesic®, a combination of acetaminophen and NSAIDs, reduces intraoperative remifentanil requirement. This study aims to investigate whether preoperative Maxigesic® administration can reduce intraoperative remifentanil requirements by performing ANI-guided remifentanil infusion for objective control of remifentanil administration.

研究设计

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

入排标准

年龄范围
19 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (19-60 years old) with ASA physical status 1, 2, 3
  • Scheduled surgery under general anesthesia

排除标准

  • The patient does not conset
  • Pregnancy
  • hepatic disorder
  • Renal disorder
  • Hypersensitivity to the NSAIDs or acetaminophen
  • Patients receiving chronic pain therapy
  • Drug dependence
  • Patients taking psychiatric drugs
  • Alcoholics
  • History of gastrointestinal ulcer or bleeding

研究组 & 干预措施

Maxigesic group

Experimental

Administration of Maxigesic before surgery start.

干预措施: Maxigesic administration (Drug)

结局指标

主要结局

Remifentanil requirement

时间窗: 3 hours, from incision to skin closure

Intraoperative remifentanil requirement

次要结局

  • postoperative analgesic requirement(1 hour, while in the recovery room)

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

In-kyong Yi

Assitant professor

Ajou University School of Medicine

研究点 (1)

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