Effects of TEAS on Postoperative Recovery of Intestinal Function in Children Undergoing Laparoscopic Appendectomy

NCT05379660 | Unknown

• 1 other identifier: 2021-015-01
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Transcutaneous Electrical Acupoint Stimulation

Outcome Measures

Primary Outcomes (1)

• the time to first bowel sound

  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.

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

Secondary Outcomes (6)

• 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

• 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 normal diet intake

  within 48 hours after surgery,from the end of surgery to the time when the patient was given normal diet

• 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

• gastroenterological hormones

  three time points: before induction of anesthesia, the end of the surgery and the first day after the operation

Study Arms (4)

T1 treatment group

EXPERIMENTAL

TEAS initiates at 30 minutes before induction and lasts for 30 minutes

Device: transcutaneous electrical acupoint stimulation

T2 treatment group

EXPERIMENTAL

TEAS initiates immediately after skin incision and lasts for 30 minutes

Device: transcutaneous electrical acupoint stimulation

T3 treatment group

EXPERIMENTAL

TEAS initiates immediately after extubating and lasts for 30 minutes

Device: transcutaneous electrical acupoint stimulation

control group

NO INTERVENTION

Electrodes are placed on the same acupoints, but no current is given

Interventions

transcutaneous electrical acupoint stimulation DEVICE

Basing on the theory of traditional Chinese medicine, bilateral Zusanli (ST 36), Shangjuxu (ST 37) and Sanyinjiao (SP 6) are elected as the acupuncture points,the electrode pads with wire are attached to the corresponding acupoints, which are connected with Hwato electric acupuncture treatment instrument,TEAS stimulation uses a dense-dispersed wave with frequencies of 2 and 100 Hz alternating every 3 s, and the intensity 5 \~ 12mA,on the first and second days after surgery, the doctor who is responsible for acupuncture will arrive at the ward in the morning and afternoon to administer TEAS stimulation at the same acupoints for 30 min in the TEAS groups

T1 treatment group; T2 treatment group; T3 treatment group

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xian Children's Hospital: lead

Study Officials

• Fang Li Yang

  Xi 'an children's hospital

  STUDY DIRECTOR

Central Study Contacts

Bin Hi Wu

CONTACT

+8618092695276; 1922703776@qq.com

Fang Li Yang

CONTACT

+8613572190398; yanglf@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 18, 2022
• Study Start: June 30, 2022
• Primary Completion: December 30, 2022
• Study Completion: April 30, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05