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临床试验/NCT05379660
NCT05379660Unknown不适用

Effects of Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery of Intestinal Function in Children Undergoing Laparoscopic Appendectomy

Xian Children's Hospital0 个研究点目标入组 200 人开始时间: 2022年6月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
主要终点
the time to first bowel sound

研究概览

简要总结

With the development of surgical techniques, laparoscopic appendectomy has become a standard therapeutic procedure for acute appendicitis in many hospitals in recent years, which is considered as an effective and safe treatment option in children. Even so, patients still experience gastrointestinal dysfunction after surgery, which is one of the most common complications in patients who have undergone major abdominal surgery. The application of laparoscopy reduces trauma in some degree, however, postoperative nausea and vomiting (PONV), abdominal distension, fart, and delayed bowel movement caused by postoperative gastrointestinal dysfunction(PGD), severely disturb patients and seriously affect the quality of patients' postoperative recovery. Previous studies have shown that the incidence of PGD can be as high as 10%-30%. For PGD, the main treatment options include the use of gastric dynamics promoting drug, non-steroidal anti-inflammatory drug, gastrointestinal (GI) decompression, nutritional support, and so forth. However, the effect of these treatments is limited, and there are varying degrees of adverse reactions, which indirectly leads to the low satisfaction of patients. Acupuncture is a form of traditional Chinese medicine and has unique advantages in the treatment of PGD, which have gradually obtained more acceptance from physicians as an alternative therapy. While transcutaneous electrical acupoint stimulation (TEAS) is one of the acupuncture-related technologies and can allow for accurate control of stimulation parameters. For this reason, it is helpful for quantitative research and widely practiced in China. Many studies have shown that TEAS combining with anesthetics can significantly enhance the analgesic effect and reduce the dosage of anesthetics, and can offer certain beneficial effects, such as alleviating preoperative anxiety and reducing postoperative pain and PONV by lessening need for anesthetic usage. It also has been found to help protect the brain, heart and other tissues, with positive benefits for gastrointestinal function by regulating vasoactive intestinal peptide levels. In practice, however, the current TEAS study focused on adults,with relatively little research on their use in children. Because of that, we applied TEAS for use in our study to observe the effect of TEAS in children's laparoscopic surgery and explore its possible mechanism.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists grade I&II,16kg/m2 ≤BMI≤30kg/m2, undergoing laparoscopic appendectomy

排除标准

  • previous history of gastrointestinal surgery or abnormal anesthesia recovery, allergy, broken and infection skin at and around the related points, long-term use of analgesic and sedative drugs, presence of severe systemic disease,and the patients drop out or are unable to complete a full follow-up for any reason

结局指标

主要结局

the time to first bowel sound

时间窗: until the time point at which the regular bowel sounds are first heard after surgery up to 1 day

It was heard by the same researcher , and defined as the first time point at which the regular bowel sounds (more than two sounds every minute) are first heard after surgery.

次要结局

  • the time to first passage of flatus(an average of 24 hours,from the end of surgery to the time of the patient's first passage of flatus)
  • inflammatory factors(three time points: before induction of anesthesia, the end of the surgery and the first day after the operation)
  • gastroenterological hormones(three time points: before induction of anesthesia, the end of the surgery and the first day after the operation)
  • the first time to normal diet intake(within 48 hours after surgery,from the end of surgery to the time when the patient was given normal diet)
  • the time to first passage of defecation(an average of 24 hours,from the end of surgery to the the time of the patient's first passage of defecation,)
  • the first time to mobilization(within 48 hours after surgery,from the end of surgery to the time when the patient is first able to leave bed)

研究者

发起方
Xian Children's Hospital
申办方类型
Other Gov
责任方
Sponsor

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