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临床试验/NCT04239794
NCT04239794进行中(未招募)不适用

The Influence of Type of Anesthesia on Postoperative Pain After Laparoscopic Colorectal Cancer Surgery: Multi-center Prospective Randomized Controlled Study

Seoul National University Hospital3 个研究点 分布在 1 个国家目标入组 468 人开始时间: 2020年2月20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
进行中(未招募)
入组人数
468
试验地点
3
主要终点
Postoperative 24 h opioid consumption

研究概览

简要总结

The investigators designed a multi-center prospective randomized controlled trial to study the influence of the type of anesthesia on postoperative pain after laparoscopic colorectal cancer surgery. Half of the participants will be anesthetized with propofol and remifentanil, while the other half will be anesthetized with sevoflurane and remifentanil during the surgery. The investigators will measure opioid consumption and pain score in the acute postoperative phase.

详细描述

Previous studies showed that patients receiving total intravenous anesthesia (TIVA) with propofol are associated with less postoperative pain and less opioid consumption compared with inhalation anesthesia. However, some studies showed conflicting results. In colorectal surgery, there are only retrospective studies that showed the analgesic effect of TIVA and inhalation anesthesia. The investigators designed a multi-center prospective randomized controlled trial and hypothesized that TIVA with propofol would be associated with reduced postoperative opioid consumption and less postoperative pain compared with sevoflurane in laparoscopic colorectal cancer 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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient scheduled for elective laparoscopic colorectal cancer surgery

排除标准

  • Conversion from laparoscopic to open surgery
  • Allergy to anesthetics and analgesics
  • Previous abdominal surgery
  • Chronic pain
  • Chronic analgesic usage

研究组 & 干预措施

Inhalation anesthesia

Active Comparator

Patients are anesthetized with sevoflurane and remifentanil infusion for maintenance of anesthesia during the surgery

干预措施: Sevoflurane (Drug)

Total intravenous anesthesia

Experimental

Patients are anesthetized with target-controlled intravenous infusion of propofol and remifentanil infusion for maintenance of anesthesia during the surgery

干预措施: Propofol (Drug)

结局指标

主要结局

Postoperative 24 h opioid consumption

时间窗: 24 hours after the surgery

Cumulative opioid consumption for pain control 24 hours after the surgery

次要结局

  • Postoperative 48 h opioid consumption(48 hours after the surgery)
  • Numerical rating scale (NRS)(24 and 48 hours after the surgery)

研究者

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

Jin-Tae Kim

Professor (full)

Seoul National University Hospital

研究点 (3)

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