Postoperative Nausea and Vomiting Clinical Trial
Official title:
The Efficacy of P6 Acupressure in Reducing Postoperative Nausea and Vomiting in Patients Undergoing Craniotomy. - a Randomized, Double-blinded, Placebo Controlled Study.
The aim of this study is to investigate if P6 acupressure may reduce postoperative nausea and vomiting in neurosurgical patients undergoing craniotomy.
The primary aim of this study is to investigate if P6 acupressure can reduce postoperative
nausea after craniotomy. Calculation of sample size was based on the assumptions to detect
at difference of 20% between the patients (38% in the control group vs 18% in the
acupressure group) for the primary endpoint; incidence of nausea during the first 24 hours
postoperatively, with a significance level 5% and a power of 80%, guided by an earlier study
with a similar population (Wang et. al. 2010) and the assumption that 38% of our patients
suffer from nausea. These assumptions suggested a sample size of 78 patients (39 patients /
group) that resulted in a sample size of 80 patients for covering attrition. Secondary aims
are to investigate if the frequency of vomiting and the need for antiemetic can be reduced
with P6 acupressure.
Patients are randomly assigned into one of two treatment groups using a computer-generated
random number table, either P6 acupressure group or placebo group. Randomization and sealing
of the study envelopes, containing all study material and following the patients all through
the study, are performed by persons from the research department, who is not involved in the
data collection. Information and study protocol are included in the envelope. The
randomization is taking place preoperatively. Sea-Band®, a single-sized elastic acupressure
band with a plastic button placed at P6 to apply pressure is used. One group will receive an
active acupressure band and the other an identical placebo band without any button. Before
entering the operation ward both wrists are marked at the place for P6, performed by staff
at the neurosurgical ward. The active acupressure bands and the placebo bands are
administered at the end of surgery. They are placed unilaterally at the wrist by the nurse
anesthetist who performs the patient's anesthesia. The manufacturer's guidelines of where
and how to place the band are included in the envelope with study material. Both the P6
acupressure bands and the placebo bands are covered with a bandage to ensure blinding to the
patients and the nursing staff involved in the postoperative care. Both the P6 acupressure
bands and the placebo bands will be removed 48 hours postoperatively. If the bands cause
discomfort, they can be removed for 30 minutes every two hours, performed by staff not
involved in the postoperative care, with instructions to cover the wrist with a cotton roll
while airing the arm, this for ensuring further blinding if the acupressure has caused any
betrayal marks.
At the end of the surgery all patients receive ondansetron 4mg IV. Droperidol IV is
administered as additional perioperative antiemetic if considered necessary. Postoperatively
rescue antiemetics are administrated according to current routines. The administered drugs
are 0,625-1,25mg droperidol and 1-4mg ondansetron, either alone or in combination.
Postoperative opioid administration (morphine and ketobemidone) are also recorded during the
time of the study
Before operation all patients are filling in a health declare formula as a routine in the
anesthetic preparation. This formula includes the four risk factors for PONV, according to
Apfel and colleagues (Apfel et al. 1999). To clarify earlier PONV there is a specific
question about this issue on the formula of written consent.
During 48 hours postoperatively the patients are evaluating their nausea which is registered
on the same formula as the frequencies of vomiting. The first evaluation is taking part when
arriving to the postoperative care unit and then every hour for the first six hours, every
third hour until hour 24 and thereafter every sixth hour from hour 25-48. A Numerical Rating
Scale (NRS) from 0-10 is used, where 0 mean no nausea at all and 10 the worst nausea
possible. The patients are asked about whether they have experienced any nausea within the
previous period of time. Assessment of nausea and registration of the vomiting frequency are
performed by staff unaware of the patient's group in the postoperative care
unit/neurosurgical ward and by the patients themselves when possible.
After discharge the data from the NRS formula are collected. The patients' journals are
screened for administrated antiemetic and opioids, for potential risk factors for PONV and
for other demographics relevant to the study outcome. All data are saved anonymously in the
software Statistical Package for Social Sciences (SPSS).
Overall PONV is defined as at least one episode of nausea or vomiting during the observation
time of 48 h. Rescue therapy is defined as at least one dosage of either droperidol or
ondansetron during the observation time of 48 h. Early PONV is defined as PONV occurring up
to 6 hours postoperatively and late PONV 7-48 hours postoperatively.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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