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Ramosetron OD Tablet and Postdischarge Nausea and Vomiting

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Seoul National University

Status and phase

Unknown
Phase 4

Conditions

Day Surgery

Treatments

Drug: Ramosetron

Study type

Interventional

Funder types

Other

Identifiers

NCT04297293
B-2002/594-003

Details and patient eligibility

About

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.

Enrollment

138 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

138 participants in 2 patient groups

Ramosetron-ODT
Experimental group
Treatment:
Drug: Ramosetron
Control
No Intervention group

Trial contacts and locations

1

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Central trial contact

Hyun-Jung Shin, MD., PhD.

Data sourced from clinicaltrials.gov

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