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临床试验/NCT03825471
NCT03825471Unknown不适用

Effects of Cranial Electrotherapy Stimulation on Anesthetics Consumption, Perioperative Cytokines Response, and Postoperative Pain in Patients Undergoing Colonic Surgery

Tri-Service General Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年1月14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
入组人数
80
试验地点
1
主要终点
dosage of intraoperative anesthetics

研究概览

简要总结

Cranial electrotherapy stimulation (CES) is a non-invasive intervention to treat anxiety, depression, insomnia, and pain. But clinical studies and applications of CES in relation to acute postoperative pain are few. tThe investigators investigate a double-blind, randomized controlled trial to figure out if intraoperative CES could decrease dosage of intraoperative anesthetics and patient-controlled analgesia (PCA) consumption in patients undergoing colon cancer surgery.

详细描述

Cranial electrotherapy stimulation (CES) is a non-invasive and safe intervention, transmitting microcurrents of brain stimulation and releasing various neurotransmitters such as endorphin and downstream hormones to modulate autonomic nervous system, as a result, for treating anxiety, depression, insomnia, and pain.

Acute postoperative pain annoys patients receiving surgery. Once acute postoperative pain is poorly controlled, it may result in adverse acute effects (i.e., physiologic and psychologic stress), chronic effects (i.e., delayed long-term recovery and chronic pain), and, in consequence, excess length of hospitalization and extra costs. Besides, inflammatory reactions mediated by immune system are formed after tissue injury (e.g. trauma, surgery, etc), release serial inflammatory cytokines and are related to pain signal transmission. However, clinical studies and applications of CES focus on management of chronic pain, modulation of mood and insomnia rather than acute postoperative pain in recent years.

The investigators investigate a double-blind, randomized controlled trial to figure out if intraoperative CES could decrease dosage of intraoperative anesthetics and patient-controlled analgesia (PCA) consumption in patients undergoing colon cancer surgery. The investigators also collect blood samples before and after surgery for analysis of serum cytokines. Meanwhile, Bispectral IndexTM (BISTM) monitoring and Analgesia Nociception Index (ANI) are prescribed during the surgery not only for measuring of the effects of anesthetics and sedatives on the brain, but also evaluating perioperative analgesia. Thereby, the effectiveness of CES for management of acute postoperative pain may introduce clinicians for alternative application of pain control after surgery in the future.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Patients undergoing colon cancer surgery

排除标准

  • presence of an implantable device (e.g., pacemaker)
  • pregnancy
  • having a known mental illness (e.g., schizophrenia, mood disorder, bipolar disorder, etc.
  • cancer of the head and neck or brain tumor or brain metastasis
  • having delirium

研究组 & 干预措施

electrotherapy

Experimental

Patients undergoing CES and general anesthesia in colon cancer surgery

干预措施: Opioid Anesthetics (Drug)

electrotherapy

Experimental

Patients undergoing CES and general anesthesia in colon cancer surgery

干预措施: electrotherapy (Procedure)

electrotherapy

Experimental

Patients undergoing CES and general anesthesia in colon cancer surgery

干预措施: colon cancer surgery (Procedure)

Opioid Anesthetics

Placebo Comparator

Patients undergoing general anesthesia in colon cancer surgery

干预措施: electrotherapy (Procedure)

Opioid Anesthetics

Placebo Comparator

Patients undergoing general anesthesia in colon cancer surgery

干预措施: Opioid Anesthetics (Drug)

Opioid Anesthetics

Placebo Comparator

Patients undergoing general anesthesia in colon cancer surgery

干预措施: colon cancer surgery (Procedure)

结局指标

主要结局

dosage of intraoperative anesthetics

时间窗: during surgery

The consumption of total amount of supplemental analgesics administered during colon cancer surgery

Rescue analgesics

时间窗: from the end of the surgery to postoperative 72 hours

The consumption of total amount of rescue analgesics administered after colon cancer surgery

Differences in Pain Intensity Between CES intervention and the control group

时间窗: from the end of the surgery to postoperative 72 hours

Pain assessment of NRS pain intensity scores and patient satisfaction assessed by the NRS through end of surgery to postoperative 72 hours

次要结局

  • dosage of patient-controlled analgesia (PCA) consumption(from the end of the surgery to postoperative 72 hours)
  • serum concentration of serum cytokine(from the beginning of the surgery to postoperative 72 hours)
  • Number of Participants with CES and control groups(during surgery)

研究者

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

Yi-hsuan Huang

Attending Physician

Tri-Service General Hospital

研究点 (1)

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