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

NCT ID: NCT05379660

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2023-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

T1 treatment group

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

Group Type: EXPERIMENTAL

transcutaneous electrical acupoint stimulation

Intervention Type: 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

T2 treatment group

TEAS initiates immediately after skin incision and lasts for 30 minutes

Group Type: EXPERIMENTAL

transcutaneous electrical acupoint stimulation

Intervention Type: 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

T3 treatment group

TEAS initiates immediately after extubating and lasts for 30 minutes

Group Type: EXPERIMENTAL

transcutaneous electrical acupoint stimulation

Intervention Type: 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

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

transcutaneous electrical acupoint stimulation

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xian Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fang Li Yang

Role: STUDY_DIRECTOR

Xi 'an children's hospital

Central Contacts

Bin Hi Wu

Role: CONTACT

1922703776@qq.com

+8618092695276

Fang Li Yang

Role: CONTACT

yanglf@fmmu.edu.cn

+8613572190398

Other Identifiers

2021-015-01

Identifier Type: -

Identifier Source: org_study_id