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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.

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. - P6NV

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00015272
Enrollment
3500
Registered
2018-08-15
Start date
2018-09-15
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

R11

Interventions

Group 1: routine pharmacological antiemetic prophylaxis against PONV Group 2: routine pharmacological antiemetic prophylaxis against PONV + stimulation of the P6-point on both arms by accupuncture or

Sponsors

Klinik für Anästhesie und Intensivtherapie, Philipps-Universität Marburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

MeasureTime frame
1) Simplified postoperative nausea and vomiting impact scale within the first 24 hours postoperatively 2) frequency of PONV (postoperative nausea and vomiting) within the first 24 hours postoperatively 3) Frequency of antiemetic rescue therapy within the first 24 hours postoperatively 4) Side effects of therapy within the first 24 hours postoperatively 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

MeasureTime frame
Primary endpoints within the first 48 hours after surgery

Countries

Germany

Contacts

Public ContactLeopold Eberhart

Philipps-Universität Marburg

eberhart@staff.uni-marburg.de49 (0) 642158-62945

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 17, 2026