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临床试验/NCT05068037
NCT05068037已完成不适用

Influence of Perioperative Medical Hypnosis and Acupuncture on Early Postoperative Recovery

University Medical Centre Ljubljana2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Postoperative consumption of antiemetics in mg

研究概览

简要总结

Perioperative stress is associated with various influences before and after surgery. Instead of benzodiazepines, patients can be calmed by non-pharmacological methods. One of these is perioperative medical hypnosis, which has also other beneficial effects such as lower opioid consumption, better wound healing, shorter hospital stays.

Acupuncture is used for analgesia. Is is effective for preventing and treating nausea and vomiting.

Hypothesis of the study is that perioperative acupuncture reduces the consumption of analgesics and anaesthetics during surgery. The investigators will also study the impact of acupuncture on postoperative nausea and vomiting and analgesic consumption in the postoperative recovery unit and the occurrence of postoperative delirium.

详细描述

Detailed Description: Perioperative stress is associated with the procedure itself, anaesthesia, as well as various influences before and after surgery. Patient's feeling of discomfort and anxiety in the preoperative period are treated with benzodiazepines. Although these drugs calm the patient, they are associated with the occurrence of postoperative delirium, especially in elderly patients. Instead of benzodiazepines, patients can be calmed by other non-pharmacological methods. One of these is perioperative medical hypnosis, which also has other beneficial effects such as lower opioid consumption, better wound healing, shorter hospital stays.

At the Clinical Department of Anesthesiology and Intensive Care at the University Medical Center Ljubljana, in cooperation with the Clinical Department of Neurosurgery, investigators have been routinely using perioperative medical hypnosis in awake brain surgeries since 2016 and have very good experience.

The risk of postoperative delirium is also reduced by the use of intravenous anesthesia and reduced use of opioids.

Acupuncture has been a recognized and well-established method for the treatment of acute and chronic pain by the WHO for several decades. With the right choice of points, in addition to treating pain, we can also reduce nausea and vomiting. It is a safe method in the hands of trained doctors, with virtually no side effects.

Perioperative acupuncture has a number of beneficial effects: it reduces the consumption of anesthetics and analgesics, reduces the number of perioperative complications, and protects vital organs.

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
Double (Participant, Outcomes Assessor)

盲法说明

The participant and the outcomes assessor will not know which intervention was used

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient consent

排除标准

  • Psychosis
  • No consent for the study
  • Pregnancy

结局指标

主要结局

Postoperative consumption of antiemetics in mg

时间窗: 24 hours

Postoperative nausea and vomiting will be measured in mg of antiemetics in PACU

次要结局

  • Postoperative consumption of analgesics in mg(24 hours)
  • Degree of satisfaction(24 hours)

研究者

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

Jasmina Markovic Bozic

Principal Investigator; assist. prof., MD, PhD

University Medical Centre Ljubljana

研究点 (2)

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