P6 acupoint stimulation for prevention of postoperative nausea and vomiting in
patients undergoing craniotomy: study protocol for a randomized controlled trial.
Author(s): Lv JQ(1), Feng RZ, Li N.
Affiliation(s): Author information:
(1)Department of Integrated Traditional and Western Medicine, West China Hospital of
Si-chuan University, Chengdu 610041, China.
Publication date & source: 2013, Trials. , 14:153
BACKGROUND: The 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/DESIGN: This 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.
DISCUSSION: The 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 REGISTRATION: This study is registered with the Chinese Clinical Trial
Registry: ChiCTR-TRC-13003026.
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