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Completed

NCT Number: NCT05408676

Comparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery

Breast cancer is one of the three most common cancers worldwide, and the primary treatment method is surgery.Since most patients are non-smokers who use opioids in the postoperative period, which are known risk factors for postoperative nausea and vomiting (PONV) according to the Apfel Risk Score. Breast surgery was identified as a strong risk factor for PONV. According to the previous studies, the incidence of PONV is 30-70% in patients undergoing the breast cancer surgery, which not only gives patients unpleasant and painful experience, but also prolongs the hospital stays and delay patient discharge and adds to hospital costs. We compared the effects of dexamethasone alone vs. in combination with Pericardium 6 (P6) electrical stimulation or granisetron for inhibition of PONV in women undergoing breast cancer surgery.

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Key information

Conditions

Mammary Cancer Breast Diseases Breast Neoplasms Nausea Neoplasms Neoplasms by Site PONV Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin and Connective Tissue Diseases Vomiting

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

About this study

186 patients who are planed to undergo elective breast cancer surgery under general anaesthesia into the following three groups: acupoint stimulation+dexamethasone (Group Acu, n=62), granisetron +dexamethasone (Group Gra, n=62), and dexamethasone alone (Group Dxm, n=62). The incidence of nausea, vomiting, and need for rescue antiemetics was recorded 2, 6, 24, and 48 h after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women undergoing breast cancer resection under general anesthesia
  • aged between 18 to 65
  • American Society of Anesthesiologists grade I-II

Exclusion criteria

  • using antiemetic drugs within 24 h before operation,
  • nausea or vomiting within 24 h before operation;
  • Alcoholic or drug abuse,
  • abnormal liver and/or kidney function, diabetic or peripheral neuropathy patients, cardiovascular disease (excluding those with controlled hypertension).
  • refuse to participate clinical trial

Treatment and study plan

electric stimulation therapy

Device

Transcutaneous electrical acupoint stimulation (TEAS) was achieved by an electrical neuromuscular stimulation device (JNR2; designed by the Department of Hand Surgery, Huashan Hospital, Fudan University, manufactured by Energy Conservation and Environment Protection Technology Company, Jiatong University, Shanghai,China)

Primary outcomes

  1. PONV within the first 24h after surgery

    Time frame: 24 hours after surgery.

    the incidence and severity of PONV

Secondary outcomes

  1. PONV within the first 48h after surgery

    Time frame: 48 hours after surgery

    the incidence and severity of PONV

  2. the use of postoperative antiemetics

    Time frame: 48 hours after surgery

    the frequency and dose of postoperative antiemetics

  3. postoperative pain score

    Time frame: 3 months after surgery

    Numeric rating scale (NRS) at 2,6,24,48 hour and 3 month after the surgery

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Acronym: P6 and PONV

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 7, 2022
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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