Ramosetron OD Tablet and Postdischarge Nausea and Vomiting

Day Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04297293
• Other study ID #: B-2002/594-003
• Status: Recruiting
• Phase: Phase 4
• Start date: May 12, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: December 2021
• Source: Seoul National University Hospital
• Contact: Hyun-Jung Shin, MD., PhD.
• Phone: 82317877499
• Email: hjshin.anesth[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Day Surgery
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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