Trial document




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  DRKS00005664

Trial Description

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Title

Electroacustimulation for the prevention of PONV-
A multimodal approach

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Trial Acronym

AkuPONV

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URL of the Trial

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Brief Summary in Lay Language

Postoperative nausea and vomiting ( PONV) is a major problem of anesthesia. Because of their impact on patient satisfaction as well as their economic and medical consequences, it is of great importance for all disciplines involved. Both prophylactic medication as well as the stimulation of the P6 acupuncture point can lead to a reduction of PONV. However, in high-risk patients a singular therapy often does not result in an adequate reduction of the incidence of PONV. Furthermore, no data are available on patient satisfaction under various forms of therapy. Because as part of the anesthesia -related risk reduction of morbidity and mortality endpoints well-being and patient satisfaction are becoming increasingly important to be examined, in this prospective randomized study possible additive effects of a multimodal concept of drug PONV prophylaxis and electrical stimulation will be investigated.
Furthermore, in a side project we aim to investigate, whether genetic variants affect the response to stimulation of the P6 acupuncture point for the purpose of reducing PONV .
To do this, we would like to form four study groups: stimulating the P6 acupuncture point/placebo, placebo / drug PONV prophylaxis, stimulation of the P6 acupuncture point / drug PONV prophylaxis, placebo/placebo. Only high-risk patients would be admitted to the study on the basis of their calculated PONV risk factors (> 60% ).

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Brief Summary in Scientific Language

Postoperative nausea and vomiting (PONV) occurs in up to 30% of unselected patients and is the most common side effect of anesthesia. PONV represents a very negative experience for many patients, which is often considered worse than post-operative pain. Prevention of PONV thereby significantly improves the postoperative assessment of well-being and satisfaction. PONV can delay the postoperative removal of the patient from the recovery room and represents the most common reason for an unplanned stationary stay of a planned outpatient. Thus, PONV leads to high economic costs. Accordingly, the avoidance and/or reduction in the incidence of PONV represents an important principle of therapy.
Through changes in the anesthesia management and use of anti-emetic agents such as dopamine antagonists, serotonin antagonists or dexamethasone, the incidence of PONV can be reduced, however not always completely avoided. Should PONV be treated prophylactically, the side effects of each individual medication must be considered and the effects carefully weighed. The prophylaxis becomes even more complicated when the drugs that are issued pre- or intra-operational, for a so-called "rescue" therapy, cannot be used. "Rescue" therapy is the therapeutic post operational use of anti emetic agents.
The quality of postoperative patient care could be vastly improved by the introduction of a safe and effective measure(s) for the prevention of PONV.
Interestingly, recent studies showed that stimulation of the P6 acupuncture point is associated with a reduced PONV incidence and a Cochrane database meta-analysis from 2009 came to the conclusion that stimulation of the P6 acupuncture point leads to a significant reduction of PONV (nausea: relative risk (RR) 0.71, 95% confidence interval (CI) 0.61 - 0.83;) Vomiting (RR 0.70, 95% CI 0.59 - 0.83;) Necessity of a 'rescue therapy' (RR 0.69, 95% CI 0.57 - 0.83). Additionally, there was no evidence of a difference between P6 acustimulation and anti-emetic therapy on the incidence of nausea (RR 0.82, 95% CI 0.60 to 1.13), vomiting (RR 1.01, 95% CI 0.77-1.31) and the necessity of a 'rescue therapy' (RR 0.82, 95% CI 0.59-1.13).
The authors of this meta-analysis came to the conclusion that further studies would not discredit the conclusions that acupuncture reduces the risk for PONV. Instead, further studies are recommended to examine whether a combination of interventions (multimodal prophylaxis), with the combination of stimulation of the acupuncture band and anti-emetic therapy, act better as any one form of intervention alone, and whether these interventions interact with each other.
We want to examine this theory in this study prospectively.

To do this, we would like to form four study groups: stimulating the P6 acupuncture point/placebo, placebo / drug PONV prophylaxis, stimulation of the P6 acupuncture point / drug PONV prophylaxis, placebo/placebo. Only high-risk patients would be admitted to the study on the basis of their calculated PONV risk factors (> 60% ).
As a secondary endpoint for this study we want to examine whether the effect of acustimulation is influenced by single nucleotide polymorphisms (SNPs) on the occurrence of PONV. To do this, the patient groups of P6 acupuncture point/placebo and placebo/placebo would be compared.

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Organizational Data

  •   DRKS00005664
  •   2014/05/08
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  •   yes
  •   Approved
  •   12-5065-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   R11 -  Nausea and vomiting
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Interventions/Observational Groups

  •   group 1: stimulation of the P6 acupuncture point for 24h/preoperative sham-antiemetic drug
  •   group 2: sham-stimulation of the P6 acupuncture point for 24h/preoperative antiemetic drug dexamethason 4 mg
  •   group 3: stimulation of the P6 acupuncture point for 24h/preoperative antiemetic drug dexamethason 4 mg
  •   group 4: sham-stimulation of the P6 acupuncture point for 24h/preoperative sham-antiemetic drug
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Placebo
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Incidence of postoperative nausea and vomiting within 6h after end of operation by questionnaire

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Secondary Outcome

1. Incidence of postoperative nause and vomiting within 24h after operation
2. usage of rescue medication within 24h

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/10/01
  •   800
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
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Additional Inclusion Criteria

Operation in the gynecology or ENT department in high risk patients for development of PONV

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Exclusion Criteria

Nickel allergy

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Addresses

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum EssenKlinik für Anästhesiologie und Intensivmedizin
    • Mr.  PD Dr.  Ulrich  Frey 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum EssenKlinik für Anästhesiologie und Intensivmedizin
    • Mr.  PD Dr.  Ulrich  Frey 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Essen
    • Mr.  PD Dr.  Ulrich  Frey 
    • Hufelandstr, 55
    • 45147  Essen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/12/15
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Trial Publications, Results and other Documents

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