Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mammary Cancer
PONV
Keywords: Mammary Cancer
PONV
electric stimulation therapy
antiemetics
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: PONV within the first 24h after surgery
timeFrame: 24 hours after surgery.
Secondary outcomes:
measure: PONV within the first 48h after surgery
timeFrame: 48 hours after surgery
measure: the use of postoperative antiemetics
timeFrame: 48 hours after surgery
measure: postoperative pain score
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jun Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: