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临床试验/jRCTs052230195
jRCTs052230195招募中不适用

Effect of Opioid Titration protocol using nociception monitors in gynecologic laparoscopic surgery with total hysterectomy: a Randomized Controlled Trial (OPTIMIST-h study)

未提供0 个研究点目标入组 75 人开始时间: 2024年3月25日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
75
主要终点
Amount of intraoperative remifentanil usage

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Treatment Purpose
盲法
Single Blind

入排标准

年龄范围
20age old over 至 85age old not(—)
性别
Female

入选标准

  • Female patients undergoing laparoscopic or robotic-assisted laparoscopic total hysterectomy
  • Patients classified as American Society of Anesthesiologists physical status 1-2
  • Patients between the ages of 20 and 85 years
  • Patients who have given written consent to participate in the study

排除标准

  • Patients who are scheduled to undergo emergency surgery
  • Patients who are being treated with a beta-blocker (oral intake or patch)
  • Patients being treated with steroids
  • Patients who cannot secure the measurement site due to amputated fingers or nail lesions
  • Patients with a pacemaker
  • Patients after heart transplantation
  • Patients using drugs that affect sinus node (atropine, anticholinergic drugs)
  • (8) Patients who are incapable of consenting
  • Patients who are judged to be inappropriate as research subjects by the investigators responsible for the study.

结局指标

主要结局

Amount of intraoperative remifentanil usage

Total amount of remifentanil divided by the usagetime (min) and ideal body weight (kg)

次要结局

  • Total amount of remifentanil administered during surgery(during surgery)
  • Comparison of biomarker values
  • Change in Quality of Recovery Score-15 values(day before surgery(Pre), postoperative day (POD) 1 and 2)
  • NRS (Numerical Rating Scale) values(day of surgery (2 hours postoperatively), at POD1, 2, 3 , and at 3 months after surgery)
  • Perioperative opioid (fentanyl) consumption(perioperative)
  • Presence of chronic postsurgical pain

研究者

发起方
未提供

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