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临床试验/NCT06004687
NCT06004687招募中1 期

Effects of Acetaminophen Preemptive Analgesia on Anesthesia Recovery Time and Postoperative Cognitive Function in Patients Undergoing Gastrointestinal Tumor Surgery

Affiliated Hospital of Nantong University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年7月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
入组人数
100
试验地点
1
主要终点
Postoperative delirium

研究概览

简要总结

Patients undergoing gastrointestinal tumor surgery are prone to delayed recovery and postoperative cognitive dysfunction due to greater trauma and longer operation time. Pre-analgesia can reverse the effects of nociceptive stimulation on recovery from general anesthesia and postoperative cognitive function. Intravenous injection of non-steroidal drugs can effectively reduce postoperative pain and the use of opioids. Therefore, This study selected acetaminophen mannitol injection for preemptive analgesia to observe the effects on anesthesia recovery time and postoperative cognitive function of patients undergoing gastrointestinal tumor surgery, providing new ideas for reducing cognitive dysfunction in patients undergoing gastrointestinal tumor surgery

详细描述

By administering acetaminophen to patients with gastrointestinal tumors before surgery, recording the time to recovery from anesthesia, and assessing cognitive function status by CAM on the first, third, and seventh day after surgery

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
Single (Investigator)

入排标准

年龄范围
16 Years 至 88 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing gastrointestinal tumor surgery
  • American Society of Anesthesiologists(ASA)≤Ⅲ

排除标准

  • History of severe adverse reactions to oral acetaminophen
  • Dysfunction of heart, liver, kidney and other important organs
  • History of chronic pain
  • Oral non-steroidal or opioid drugs
  • Patients who do not accept clinical trials

研究组 & 干预措施

By applying acetaminophen mannitol to patients with gastrointestinal tumors before surgery

Active Comparator

Acetaminophen mannitol injection 50ml(500mg) intravenously pumped 30 minutes before surgery

干预措施: acetaminophen mannitol (Drug)

By applying normal saline to patients with gastrointestinal tumors before surgery

Placebo Comparator

Normal saline injection 50ml intravenously pumped 30 minutes before surgery

干预措施: Normal saline (Drug)

结局指标

主要结局

Postoperative delirium

时间窗: 1/3/7 days after the surgery

The confusion assessment method (CAM) was used to assess postoperative cognitive dysfunction

次要结局

  • Recovery time(immediately after the surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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