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临床试验/NCT04281628
NCT04281628已完成4 期

Comparison Between Low-dose Ketamine Infusion and Intravenous Morphine Infusion for Analgesia in Laparotomy Myomectomy: A Double-blind, Randomized, Controlled Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年2月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
80
试验地点
1
主要终点
total Amount of Morphine need intraoperative and postoperative

研究概览

简要总结

Ketamine is an antagonist of N-methyl-d-aspartate (NMDA) receptor that not only abolishes peripheral afferent noxious stimulation, but it may also prevent central sensitization of nociceptors as shown in animal studies with excellent analgesic property even in subanesthetic doses. It is readily available and is being used currently, even by non-Anesthesiologists, to provide "sedation" for minor procedures.(.. Low-dose ketamine infusion in the perioperative period has shown to produce analgesia and decrease the requirements of opioid analgesics.. In obstetrics, it is being used as an adjunct to an inadequately functioning spinal anesthesia for caesarean section, as an induction agent for cesarean section and also to provide analgesia during labor in intermittent boluses.

详细描述

Ketamine is an antagonist of N-methyl-d-aspartate (NMDA) receptor that not only abolishes peripheral afferent noxious stimulation, but it may also prevent central sensitization of nociceptors as shown in animal studies with excellent analgesic property even in subanesthetic doses. It is readily available and is being used currently, even by non-Anesthesiologists, to provide "sedation" for minor procedures.(.. Low-dose ketamine infusion in the perioperative period has shown to produce analgesia and decrease the requirements of opioid analgesics.. In obstetrics, it is being used as an adjunct to an inadequately functioning spinal anesthesia for caesarean section, as an induction agent for cesarean section and also to provide analgesia during labor in intermittent boluses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Control group

Placebo Comparator

control group: where normal saline will be administered as a loading dose then infused with same rate of another group, throughout the whole surgery.

干预措施: Control group (Drug)

结局指标

主要结局

total Amount of Morphine need intraoperative and postoperative

时间窗: up to 24 hours

adjusted to keep the HR and mean arterial blood pressure within 20% of the pre induction values. Starting from the induction till the end of the operation.

次要结局

  • Number of Participants with sleep disturbances(up to 24 hours)
  • Number of Participants with nausea and vomiting(up to 24 hour)
  • Number of Participants with sedation(up to 24 hour)
  • postoperative pain score(up to 24 hours)
  • Number of Participants with hallucinations(up to 24 hours)
  • duration of surgery(UP TO 1 HOURE)

研究者

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

Amr Samir Wahdan

Lecturer of Anesthesia, Pain management and Surgical ICU

Cairo University

研究点 (1)

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