Ramosetron OD Tablet and Postdischarge Nausea and Vomiting

Phase 4

• Conditions: Day Surgery
• Interventions: Drug: Ramosetron

• Registration Number: NCT04297293
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-05
• Study Start: 2020-05-12
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2021-12-22
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ramosetron-ODT	Ramosetron	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of