Abstract

BackgroundThe incidence of postoperative nausea and vomiting (PONV) is 50 to 79% after neurosurgery. Our study is designed to evaluate the efficacy of pericardium 6 (P6; also known as Neiguan) acupoint stimulation versus placebo, and versus routine antiemetic for the prevention of PONV after craniotomy, as well as to compare the efficacy of invasive acupuncture with non-invasive transcutaneous electrical nerve stimulation (TENS) on P6.Methods/designThis is a single-center, prospective, double-blind, five-arm, parallel-group, randomized controlled trial (RCT). All groups will be given routine intravenous ondansetron 8 mg administered before skin closure. Upon regaining consciousness from general anaesthesia, patients will receive one of five interventions: 1) P6 acupuncture bilaterally for 30 minutes, stimulated every 10 minutes to keep de qi sensation; 2) sham acupuncture bilaterally for 30 minutes with no stimulation; 3) P6 stimulation via active TENS electrodes bilaterally for 30 minutes, with stimulation frequency and intensity set to when de qi sensation is felt; 4) sham P6 stimulation via inactive TENS electrode bilaterally for 30 minutes; and 5) usual practice of pharmacological emesis prevention. The incidence of postoperative vomiting during the first 24 hours is the main outcome. Secondary outcomes include: complete response rate, severity of nausea, total rescue metoclopramide dose used and patient satisfaction with PONV management.DiscussionThe results from this study could potentially confirm that P6 acupoint stimulation is an effective adjunct to standard antiemetic drug therapy for the prevention of PONV in patients undergoing craniotomy. Our study may also confirm that conventional acupuncture is more effective than TENS.Trial registrationThis study is registered with the Chinese Clinical Trial Registry: ChiCTR-TRC-13003026.

Highlights

  • The incidence of postoperative nausea and vomiting (PONV) is 50 to 79% after neurosurgery

  • The results from this study could potentially confirm that pericardium 6 (P6) acupoint stimulation is an effective adjunct to standard antiemetic drug therapy for the prevention of PONV in patients undergoing craniotomy

  • The primary objective of this study is to evaluate the efficacy of P6 acupoint stimulation versus placebo, and versus routine antiemetic for the prevention of PONV in patients undergoing craniotomy under general anesthesia

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Summary

Introduction

The incidence of postoperative nausea and vomiting (PONV) is 50 to 79% after neurosurgery. Due to the limited efficacy and many side effects of drug therapy, various non-pharmacological techniques have been used in clinical practice These therapies include acupuncture, acupressure, transcutaneous electrical nerve stimulation (TENS), electro-acupuncture, and others. According to the theory of traditional Chinese medicine (TCM), performing surgery breaks the balanced state of the human body and disturbs the movement of both qi and blood. When this happens, stomach qi will reverse its direction and go upward, causing nausea and vomiting. One of P6’s main functions is to regulate the function of the stomach to avoid the adverse flow of qi, it is an effective acupoint for preventing nausea and vomiting

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