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A study on the efficacy of aprepitant injection (submicron emulsion) in preventing postoperative nausea and vomiting in patients undergoing breast cancer surgery

A study on the efficacy of aprepitant injection (submicron emulsion) in preventing postoperative nausea and vomiting in patients undergoing breast cancer surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113173
Enrollment
Unknown
Registered
2025-11-25
Start date
2023-06-08
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

The Arimidex group:Aripiprazole group: Before the induction of anesthesia during the surgery, 130mg of aripiprazole injection (microemulsion) was intravenously administered. 18mL (130mg dose) of aripi
Control group:Control group: 18 ml of normal saline was intravenously injected 2 minutes before the induction of anesthesia, and 4 mg of ondansetron was intravenously injected at the end of the surger

Sponsors

Shanxi Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for elective breast cancer surgery under general anesthesia with an operation time of no more than 3 hours; 2. Patients aged 18 to 65 years, weighing 48 to 80 kg, with no restrictions on race; 3. American Society of Anesthesiologists (ASA) physical status classification I to II; 4. Agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who refuse to participate in this study; 2. Those who are allergic to the active ingredients of aprepitant and ondansetron or any of the excipients; 3. Those who have taken pimozide; 4. Those who have received anti-nausea and anti-vomiting drugs, steroid drugs or any other drugs known to cause nausea and vomiting within 72 hours before the surgery; 5. Those who have obvious organic functional abnormalities in the heart, lungs, liver, kidneys, etc. before the surgery; 6. Those who have severe neurological or mental abnormalities before the surgery; 7. Those with a BMI greater than 30 or less than 18 kg/m^2; 8. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Complete response rate (CR);

Secondary

MeasureTime frame
The incidence rate of nausea and vomiting;PACU stay time;The severity of nausea;The usage situation of antiemetic rescue drugs;Patient satisfaction.;

Countries

China

Contacts

Public ContactTian Shouyuan

Shanxi Provincial Cancer Hospital

chinatsyjj@126.com+86 138 0340 1773

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026