Mammary Cancer, PONV
Conditions
Keywords
Mammary Cancer, PONV, electric stimulation therapy, antiemetics
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.
Interventions
DEVICEelectric stimulation therapy
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)
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PONV within the first 24h after surgery | 24 hours after surgery. | the incidence and severity of PONV |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PONV within the first 48h after surgery | 48 hours after surgery | the incidence and severity of PONV |
| the use of postoperative antiemetics | 48 hours after surgery | the frequency and dose of postoperative antiemetics |
| postoperative pain score | 3 months after surgery | Numeric rating scale (NRS) at 2,6,24,48 hour and 3 month after the surgery |
Countries
China
Outcome results
None listed