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

NCT05408676 | Completed

• 1 other identifier: 2110244-11
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Mammary Cancer; PONV

Keywords

Mammary Cancer; PONV; electric stimulation therapy; antiemetics

Outcome Measures

Primary Outcomes (1)

• PONV within the first 24h after surgery

  the incidence and severity of PONV

  24 hours after surgery.

Secondary Outcomes (3)

• PONV within the first 48h after surgery

  48 hours after surgery

• the use of postoperative antiemetics

  48 hours after surgery

• postoperative pain score

  3 months after surgery

Study Arms (3)

Group Acu

EXPERIMENTAL

a surface electrode was applied in the induction room to the P6 acupoint on the dominant upper extremity, located ∼4 cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode on the opposing dorsal aspect of the forearm. When the patient enters the operating room， an investigator connected the device to both electrodes with electrical wires, set initial electric stimulating current at 1 mA with the frequency at 2 Hz(square-wave pulses of 0.2 ms), gradually increased the current intensity until the patient felt pain or reached the discomfort threshold (ranging from 6 to 20 mA), and maintained the stimulation until end of operation. At the start of skin closure, saline (3 ml) was administered i.v.

Device: electric stimulation therapy

Group Gra

SHAM COMPARATOR

Group Gra receive the same protocol but silicone covers were attached to both electrodesin to achieve an inert control. At the start of skin closure, granisetron (3 mg; Group Trp) was administered i.v.

Device: electric stimulation therapy

Group Dxm

SHAM COMPARATOR

Group Dxm receive the same protocol but silicone covers were attached to both electrodesin to achieve an inert control. At the start of skin closure, saline (3 ml) was administered i.v.

Device: electric stimulation therapy

Interventions

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)

Group Acu; Group Dxm; Group Gra

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Postoperative Nausea and Vomiting

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Jun Zhang, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 7, 2022
• Study Start: June 10, 2022
• Primary Completion: March 30, 2023
• Study Completion: May 2, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)