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

PONV Clinical Trial

— P6 and PONV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05408676
• Other study ID #: 2110244-11
• Status: Completed
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: May 2, 2023

Study information

• Verified date: September 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: May 2, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Mammary Cancer
• PONV
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Device:
• electric 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)

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PONV within the first 24h after surgery	the incidence and severity of PONV	24 hours after surgery.
Secondary	PONV within the first 48h after surgery	the incidence and severity of PONV	48 hours after surgery
Secondary	the use of postoperative antiemetics	the frequency and dose of postoperative antiemetics	48 hours after surgery
Secondary	postoperative pain score	Numeric rating scale (NRS) at 2,6,24,48 hour and 3 month after the surgery	3 months after surgery