Background
The efficacy of pericardium 6 (P6) acupoint stimulation to reduce the incidence of postoperative nausea and vomiting (PONV) has been proven in several randomised controlled clinical trials. However, little is known about the effectiveness in daily practice and its use in combination with traditional pharmacologic approaches.
Methods
The primary objective of the P6NV study is to determine whether intraoperative acustimulation (acupuncture or acupressure) at the point P6 provides additional benefit when applied along with customary prophylactic intravenous antiemetics administered according to the local standard operating procedures (SOP). The primary endpoint is the incidence and severity of PONV within the first 24 h postoperatively reported with a validated postoperative nausea and vomiting intensity scale. The patient-reported outcome of perioperative quality of life (using the PPP33-questionnaire) and the detection of antiemetic-related side effects as well as the severity of PONV (via a standardised questionnaire) are secondary study objectives. P6NV is a national, multicentre, randomised, prospective, patient- and examiner-blinded interventional study and will be performed on 3500 adult patients with ASA classification I–III undergoing elective surgery under general anaesthesia and hospitalised for at least 24 h. Participating anaesthesiologists commit themselves to administer customised conventional antiemetic prophylaxis according to the local SOP by signing a statement before randomisation. The intervention group receives bilateral acupuncture or acupressure at P6. The control group receives no intervention. Before extubation, acustimulation is removed.
Discussion
Since P6 acustimulation is performed by a wide range of anaesthesiologists receiving written and verbal information on acustimulation beforehand, this trial will provide information on the effectiveness of an ad hoc implementation of P6 stimulation techniques in anaesthesia departments using traditional pharmacologic PONV prophylaxis.
Trial registration
DRKS DRKS00015272. Registered on August 15, 2018.
Background: The efficacy of Pericardium 6 (P6) acupoint stimulation to reduce the incidence of postoperative nausea and vomiting (PONV) has been proven in several randomised controlled clinical trials. However, little is known about the effectiveness in daily practise and its use in combination with traditional pharmacologic approaches. Methods: Primary objective of the P6NV study is to determine whether intraoperative acustimulation (acupuncture or acupressure) at the point P6 provides additional benefit when applied along with customary prophylactic intravenous antiemetics administered according to local standard operating procedures (SOP). Primary endpoint is the incidence and severity of PONV within the first 24 hours postoperatively reported with a validated postoperative nausea and vomiting intensity scale. The patient-reported outcome of perioperative quality of life (using the PPP33-questionnaire) and the detection of antiemetic-related side-effects as well as severity of PONV (via a standardised questionnaire) are secondary study objectives. P6NV is a national, multicentre, randomised, prospective, patient- and examiner-blinded interventional study and will be performed in 3500 adult patients with ASA-classification I-III undergoing elective surgery under general anaesthesia and hospitalised for at least 24 hours. Participating anaesthesiologists commit themselves to administer customised conventional antiemetic prophylaxis according to local SOP by signing a statement before randomisation. The intervention group receives bilateral acupuncture or acupressure at P6. The control group receives no intervention. Before extubation, acustimulation is removed. Discussion: Since P6-acustimulation is performed by a wide range of anaesthesiologists receiving written and verbal information on acustimulation beforehand, this trial will provide information on the effectiveness of an ad-hoc implementation of P6-stimulation techniques anaesthesia departments using traditional pharmacologic PONV-prophylaxis. Trial registration: The trial was registered at DRKS on August 15th, 2018. Identifier: DRKS00015272. URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID= DRKS00015272
ZusammenfassungDie Rapid Sequence Induction and Intubation (RSII) ist das Anästhesieverfahren der Wahl bei aspirationsgefährdeten Patienten, die sich einem operativen Eingriff in Allgemeinanästhesie unterziehen müssen. Die klassische RSII beschränkt sich auf wenige Behandlungsempfehlungen. Diesen liegen selten evidenzbasierte Erkenntnisse zugrunde. Neue Techniken (z. B. Videolaryngoskopie) sowie neue Diagnostika (z. B. Sonografie) erfordern eine Reevaluation der traditionell praktizierten Techniken. In diesem Artikel werden nichtpharmakologische Behandlungsstrategien der RSII behandelt und alte sowie neue Methoden zur Minimierung des Aspirationsrisikos kritisch diskutiert. Zu diesen gehören neben der Magensonde und der Magensonografie die Abläufe rund um die Narkoseeinleitung, wie Lagerung, Zwischenbeatmung, Relaxometrie sowie der Krikoid- bzw. linksparatracheale Druck. Innerklinisch müssen allen Teammitgliedern Behandlungsstandards für die RSII bekannt und die Abläufe etabliert und eingeübt sein. Ziel dieses Artikels ist es, Systematiken darzustellen, die eine Entscheidungsgrundlage für lokale Handlungsanweisungen bilden können.
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