Clinical trial NCT05379660: Effects of TEAS on Postoperative Recovery of Intestinal Function in Children Undergoing Laparoscopic Appendectomy
Official title: Effects of Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery of Intestinal Function in Children Undergoing Laparoscopic Appendectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transcutaneous Electrical Acupoint Stimulation
Lead sponsor: Xian Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2022-05-18
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: the time to first bowel sound
timeFrame: until the time point at which the regular bowel sounds are first heard after surgery up to 1 day
Secondary outcomes:
measure: the time to first passage of flatus
timeFrame: an average of 24 hours,from the end of surgery to the time of the patient's first passage of flatus
measure: the time to first passage of defecation
timeFrame: an average of 24 hours,from the end of surgery to the the time of the patient's first passage of defecation,
measure: the first time to normal diet intake
timeFrame: within 48 hours after surgery,from the end of surgery to the time when the patient was given normal diet
measure: the first time to mobilization
timeFrame: within 48 hours after surgery,from the end of surgery to the time when the patient is first able to leave bed
measure: gastroenterological hormones
timeFrame: three time points: before induction of anesthesia, the end of the surgery and the first day after the operation
measure: inflammatory factors
timeFrame: three time points: before induction of anesthesia, the end of the surgery and the first day after the operation
Other outcomes:
Locations:
Study officials:
affiliation: Xi 'an children's hospital
name: Fang Li Yang
role: STUDY_DIRECTOR
References: