The use and protective effects of transcutaneous electrical acupoint stimulation during abdominal surgery: study protocol for a multicenter randomized parallel controlled trial.

BACKGROUND

Acupuncture-balanced anesthesia has been found to offer protective benefits. Electrical stimulation at certain acupoints can potentially promote perioperative gastrointestinal function recovery. The purpose of this study is to explore the effects of acupuncture-balanced anesthesia on the postoperative recovery of gastrointestinal function, on anesthesia strategies for abdominal surgery, on postoperative pain treatment, and on any associated complications or alterations in immune function. We further seek to verify the protective effects of transcutaneous electrical acupoint stimulation (TEAS), to explore possible underlying neuroimmune-endocrine mechanisms, and to thereby develop an optimized acupuncture-balanced anesthesia strategy suitable for abdominal surgery. Together, these findings will provide a scientific basis for the clinical utilization of acupuncture-balanced anesthesia in the context of abdominal surgery.

METHODS/DESIGN: This study is a multicenter, large-sample, randomized placebo-controlled trial. All subjects will be patients undergoing elective gastric or colorectal surgery. In Part 1, these patients will be stratified according to surgical site (gastric or colorectal), and randomly divided into four groups based on different perioperative interventions: Con group, which will undergo sham TEAS before, during, and after surgery; T1 group, which will receive TEAS during the preoperative and intraoperative periods, and sham TEAS during the postoperative period; T2 group, which will receive TEAS during the preoperative period, sham TEAS during the intraoperative period, and TEAS during the postoperative period; and T3 group, which will receive TEAS before, during, and after operation. Part 2 of this study will focus solely on colorectal surgery patients. All patients will receive TEAS during the preoperative and intraoperative periods, and they will be randomized into four groups according to different postoperative treatments: Con' group, which will not receive TEAS; T1' group, which will receive sham TEAS; T2' group, which will receive 5-Hz TEAS; and T3' group, which will receive 100-Hz TEAS. Venous blood (5 ml) will be used to measure immunological and inflammatory indexes both at the preoperative stage prior to TEAS and 4-5 days after operation. The primary outcome will be the time to first bowel sounds after surgery. Secondary outcomes will include gastrointestinal functional recovery, analgesic efficacy during the postoperative period, acupuncture-balanced anesthesia efficacy, postoperative nausea and vomiting, and postoperative complications.

DISCUSSION

This study is designed to investigate the clinical value of TEAS during various perioperative periods in those undergoing abdominal surgery, with the overall goal of evaluating the clinical value and advantages of acupuncture-balanced anesthesia, and of providing new strategies for improving patient prognoses.

TRIAL REGISTRATION

Chinese Clinical Trial Registry, ChiCTR-TRC-14004435. Registered on 26 March 2014.