Skip to content

A comparative study on dosing strategy of ramosetron to prevent postoperative nausea and vomiting in high-risk patients undergoing elective breast surgery

A comparative study on dosing strategy of ramosetron to prevent postoperative nausea and vomiting in high-risk patients undergoing elective breast surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006186
Enrollment
254
Registered
2021-05-26
Start date
2021-07-01
Completion date
Unknown
Last updated
2021-06-24

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

Conditions

None listed

Interventions

Procedure/Surgery : Standard group: Ramosetron 0.3 mg is intravenously administered once at the end of surgery. As a placebo, normal saline (1 ml) is intravenously administered daily until 2 days afte

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Female 2. Patients 20 to 70 years old 3. Body weight ? 45 kg 4. American Society of Anesthesiologist Physical Status 1, 2 or 3 5. Apfel simplified PONV risk score ? 3 (3 or more of the 4 items below) • Female • History of PONV and/or motion sickness • Nonsmoking status • Use of postoperative opioids 6. Patients undergoing elective breast surgery (breast-conserving surgery or mastectomy) 7 Patients who signed a written informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test 2. Patients with known hypersensitivity to ramosetron 3. Patients with known hypersensitivity to oxycodone 4. Clinically significant impairment of renal function, defined by estimated GFR < 60 ml/min or a need for hemodialysis 5. Family history of malignant hyperthermia 6. Patients who are considered by the investigator to be unsuitable to participate in the study for any other reason not mentioned in the inclusion and exclusion criteria

Design outcomes

Primary

MeasureTime frame
Frequency of nausea, vomiting, or retching for 48 hours after the end of surgery

Secondary

MeasureTime frame
- Severity of PONV assessed by Rhodes index for nausea, vomiting and retching at 6, 24, and 48 hours after the end of surgery (0-32) - Frequency and amount of rescue antiemetics usage for 48 hours after the end of surgery

Countries

Korea, Republic of

Contacts

Public ContactByung-Moon Choi

Asan Medical Center

rios76@hanmail.net+82-2-3010-1704

Outcome results

None listed

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