跳至主要内容
临床试验/NCT06708169
NCT06708169招募中不适用

Effect of Preemptive Education on the Incidence of Maternal Intraoperative Shivering in Elective Cesarean Delivery: a Randomized Controlled Trial

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年12月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
130
试验地点
2
主要终点
Number of participants with intraoperative maternal shivering

研究概览

简要总结

The goal of this study is to learn about the effect of preemptive education on reducing intraoperative maternal shivering in elective cesarean delivery. The main question it aims to answer is:

Does preemptive education by anesthesiologists reduce intraoperative maternal shivering in elective cesarean delivery?

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
19 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 19 years or older
  • Gestational age 37 weeks or above
  • Elective surgey

排除标准

  • Emergency surgery
  • Any sign of onset of labor
  • Difficulty with communication
  • Contraindications of spinal anesthesia
  • Pre-eclampsia

结局指标

主要结局

Number of participants with intraoperative maternal shivering

时间窗: From the moment the patient enters the operating room (0 minute) until leaving the operating room on the same day, expected to be up to 180 minutes.

Record when shivering occurred within the time frame

次要结局

  • Intraoperative body temperature(0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after entering the operating room until the end of surgery.)
  • Intraoperative pain (Numeric rating scale, NRS).(From the moment the patient enters the operating room (0 minute) until leaving the operating room on the same day, expected to be up to 180 minutes.)
  • Spinal anesthesia level (dermatome)(From the intrathecal injection (0 minute) until at the end of surgery (0, 5, 10, 25, 40, 55, 75 minute, at the end of surgery))
  • Post-operative spinal anesthesia level in recovery room(From the time the patient enters the recovery room (0 minute) until leaving the recovery room (0, 15, 30, 45 minute, at the time the patient leaves the recovery room))
  • Number of Participants with Post-operative shivering in recovery room(From the time the patient enters the recovery room (0 minute) until leaving the recovery room (0, 15, 30, 45 minute, at the time the patient leaves the recovery room))
  • Post-operative body temperature in recovery room(From the time the patient enters the recovery room (0 minute) until leaving the recovery room (0, 15, 30, 45 minute, at the time the patient leaves the recovery room))
  • Post-operative nausea and vomiting in recovery room (by questionnaire)(From the time the patient enters the recovery room (0 minute) until leaving the recovery room (0, 15, 30, 45 minute, at the time the patient leaves the recovery room))
  • Patient's satisfaction by questionnaire(From the end of surgery until 24 hours after surgery)
  • Pain (assessed by NRS) until post-operative day 1(At 6, 12, 18, 24 hours after the end of surgery)
  • Analgesic dosage (Morphile miligram equivalents) until post-operative day 1(From the end of surgery until 24 hours after surgery)
  • Obstetric quality of recovery until post-operative day 1(At 24 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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