Ramosetron OD Tablet and Postdischarge Nausea and Vomiting

Effects of Ramosetron Orally Disintegrating Tablet on the Prophylaxis of Postdischarge Nausea and Vomiting in High-risk Patients Undergoing Day Surgery Under General Anesthesia

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04297293

Enrollment

138

Registered

2020-03-05

Start date

2020-05-12

Completion date

2022-02-28

Last updated

2021-12-22

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

Conditions

Day Surgery

Brief summary

Postoperative nausea and vomiting after general anesthesia is one of the common anesthetic complications. If the patient is discharged from the hospital after surgery, proper treatment may be delayed or impossible if nausea and vomiting occurred. Thus, it is necessary to prevent these symptoms beforehand. Patients who underwent day-surgery will be treated with prophylactic ramosetron orally disintegrating tablets to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.

Interventions

DRUGRamosetron

Ramosetron orally disintegrating tablet 0.1 mg is administered after discharge (postoperative day 1 and day 2)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Patients who undergo day-surgery under general anesthesia and are discharged on the day of surgery

Exclusion criteria

* Pregnancy or breastfeeding * Patients who are taking other serotonin receptor antagonists * Patients who have galactose intolerance or Lapp lactase deficiency * patients who have glucose-galactose malabsorption

Design outcomes

Primary

Measure	Time frame
The change in the occurrence of postoperative nausea	Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
The change in the occurrence of postoperative vomiting	Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

Secondary

Measure	Time frame	Description
The change in the severity of postoperative nausea	Postoperative 30 minute, 3 hour, 24 hour, and 48 hour	Numerical rating scale range from 0 to 100 (0 = no pain, 100 = the most severe pain imaginable)
The change of patient's satisfaction score	Postoperative 30 minute, 3 hour, 24 hour, and 48 hour	Numerical rating scale range from 0 to 100 (0 = no pain, 100 = the most severe pain imaginable)
The change in the number of postoperative administration of rescue antiemetic drug	Postoperative 30 minute, 3 hour, 24 hour, and 48 hour	—

Countries

South Korea

Contacts

Primary ContactHyun-Jung Shin, MD., PhD.

hjshin.anesth@gmail.com82317877499

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026