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临床试验/NCT03664622
NCT03664622已完成不适用

Does Low-Dose Ketamine Infusion or Intravenous Morphine Infusion During Abdominoplasty Change Postoperative Pain Profile? : A Double-Blind, Randomized, Controlled Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年9月15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
已完成
入组人数
160
试验地点
1
主要终点
dose of fentanyl

研究概览

简要总结

The aim of this study is to evaluate the efficacy of intravenous low dose ketamine infusion versus morphine infusion analgesia for pain reduction in Abdominoplasty surgery

详细描述

Abdominoplasty is considered one of the most commonly performed cosmetic procedures. According to statistics from the International Society of Aesthetic Plastic Surgery, a total of 758,590 abdominoplasties were performed in the world in 2016. This is an increase of 72.95% in comparison with 2011, making it the fourth most common cosmetic procedure. Given the increasing number of abdominoplasties performed, the importance of understanding the possible complications and morbidity associated with the procedure is critical. One of these complications is the postoperative pain. With adequate postoperative pain control, the patients met discharge criteria sooner and this helps in shortening the hospital stay, better overall patient satisfaction, and decreased hospital costs. Therefore, the severity of this problem and the all drug agent used to prevent and treat postoperative pain best interest to be aware in the anesthesiologists. Traditionally, analgesia for abdominal wall surgery is provided either by systemic drugs such as opioids, nonsteroidal anti-inflammatories, alpha 2 agonists and paracetamol or by epidural analgesia. However, Opioids, such as morphine or fentanyl, remain the mainstay of postoperative analgesic regimens for patients after abdominal wall surgery. The pain is not always fully relieved by such agents, and often patients develop tolerance to them. The ever-increasing doses of opioids are clearly not without their adverse effects. (5) For this Alternative approaches, which reduce the requirement for strong opioids post-operative, are required. Recently, interest has focused on the use of N-methyl-D-aspartate (NMDA) receptor antagonists for the management of postoperative pain. Ketamine exerts its main analgesic effect by antagonism of NMDA receptors that not only abolishes peripheral afferent noxious stimulation, but it may also prevent central sensitization of nociceptors as shown in animal studies with the excellent analgesic property even in subanesthetic doses. (6) Various recently published studies have talked about the analgesic effect of low-dose ketamine (7,8) however, all of this study are relatively short procedure time, reduced surgical stimulation and small sample size. The aim of this study is to evaluate the efficacy of intravenous low dose ketamine infusion versus morphine infusion analgesia for pain reduction in Abdominoplasty surgery

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status I or II
  • patients aged between 18-50 years old. -

排除标准

  • those who refused to participate
  • ASA physical status III, IV, patients younger than 18 years or older than 50 years old
  • super morbid obesity with BMI 50, history of epilepsy
  • patients having a history of parenteral or oral analgesics within the last 24 hours before
  • initiation of operation
  • those having an allergy to study agents.

研究组 & 干预措施

group K

Experimental

patients with a ketamine infusion intraoperative

干预措施: Ketamine (Drug)

group M

Experimental

patients with a Morphine infusion intraoperative

干预措施: Morphine (Drug)

结局指标

主要结局

dose of fentanyl

时间窗: 4 hours

Amount of fentanyl needed intraoperative and postoperative after extubation, and every hour postoperative for four hours.

次要结局

  • pain assessment: VAS (Visual analogue scale)(4 hours)

研究者

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

Hassan Mohamed Ali

associate professor

Cairo University

研究点 (1)

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