跳至主要内容
临床试验/NCT02116257
NCT02116257已完成不适用

The Opioid-sparing Effect and Reduced PONV Using Propacetamol in PCA Among Patients With High Risk of PONV

Yonsei University1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2013年11月最近更新:
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
108
试验地点
1
主要终点
Incidence of PONV

研究概览

简要总结

While Patient-controlled analgesia (PCA) has the advantage of effectively reducing the degree of postoperative pain, it can also affect the patient's outcome by several adverse effects such as postoperative nausea and vomiting (PONV). Especially for high risk group of patients for PONV, the ideal regimen for sufficient analgesia with minimal adverse effect needs to be sought. Propacetamol is known for its effective, rapid analgesia, opioid-sparing effect, and is used widely for post operative pain management. This study aims to see the opioid-sparing effect and the degree of PONV when propacetamol is added to PCA for high risk PONV patients.

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Patients scheduled for either 1-2 level spine fusion or laminectomy
  • ASA (American Society of Anesthesiology) physical status 1 or 2
  • Non-smoking female patients, between the age 20 and 65

排除标准

  • Administration of any anti-emetic agents within 24 hours prior to surgery
  • Administration of any opioid agents within 7 days prior to surgery
  • Regular administration of any steroid agents
  • Drug or alcohol-abuser
  • Patients with bowel movement disorder, liver or renal impairment, insulin-dependent diabetes. Patients who are pregnant, illiterate, or foreign.
  • Patients administered to Intensive Care Unit after surgery

研究组 & 干预措施

Propacetamol

Experimental

干预措施: Propacetamol (Drug)

PCA regimen

Placebo Comparator

routine PCA drug

干预措施: PCA regimen (Drug)

结局指标

主要结局

Incidence of PONV

时间窗: from immediate postop to 24 hours after the surgery

Incidence of postoperative nausea, vomiting - Number of events

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

The Opioid-sparing Effect and Reduced PONV Using... | 临床试验