Randomized, patient- and observer-blinded evaluation of P6 stimulation for the prevention of nausea and vomiting in the postoperative period in patients receiving routine pharmacological prophylaxis.
- Conditions
- R11Nausea and vomiting
- Registration Number
- DRKS00015272
- Lead Sponsor
- Klinik für Anästhesie und Intensivtherapie, Philipps-Universität Marburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 3500
Patients undergoing scheduled surgery for general anesthesia.
- Patients 18 years and older
- Patients are able to consent
- sufficient command of the German language to be able to carry out a medical anamnesis and a postoperative survey without a translator
- Patients agree to undergo P6 acupressure / P6 acupuncture
- Patients have a PONV risk, which requires one or more of the following pharmacological intervention (s) against PONV at the treating clinic according to the instructions given there or in the opinion of the attending anesthesiologist.
-- Application of 4-8 mg dexamethasone
-- Application of 4-8 mg ondansetron
-- Application of 1 mg granisetron
-- Administration of 0.5-1.5 mg droperidol
-- Application of 0.5-1.5 mg haloperidol
-- Application of 50-70 mg dimenhydrinate
-- TIVA (instead of anesthesia maintenance with a volatile anesthetic)
- Rejection of study participation by patients
- Patient already participated in study
- patients undergoing chemotherapy or antineoplastic therapy / radiotherapy within the last 4 weeks
- Regional anesthetic procedure as the sole anesthesia procedure
- Pregnancy and breast feeding period
- Foreseeable requirement of postoperative post-ventilation / intensive care
- Dementia
- Preoperative nausea
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Simplified postoperative nausea and vomiting impact scale within the first 24 hours postoperatively<br>2) frequency of PONV (postoperative nausea and vomiting) within the first 24 hours postoperatively<br>3) Frequency of antiemetic rescue therapy within the first 24 hours postoperatively<br>4) Side effects of therapy within the first 24 hours postoperatively<br><br>Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth 2012; 108: 423-429
- Secondary Outcome Measures
Name Time Method Primary endpoints within the first 48 hours after surgery