Ramosetron OD Tablet and Postdischarge Nausea and Vomiting

NCT04297293 | Unknown Phase 4

• 1 other identifier: B-2002/594-003
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Day Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• The change in the severity of postoperative nausea

  Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

• The change of patient's satisfaction score

  Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

• The change in the number of postoperative administration of rescue antiemetic drug

  Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

Study Arms (2)

Ramosetron-ODT

EXPERIMENTAL

Drug: Ramosetron

Control

NO INTERVENTION

Interventions

Ramosetron DRUG

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

Ramosetron-ODT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

RECRUITING

Related Publications (1)

• Shin HJ, Park YH, Chang M, Chae YJ, Lee HT, Lee OH, Min SK, Do SH. Effects of ramosetron orally disintegrating tablets on the prophylaxis of post-discharge nausea and/or vomiting in female patients undergoing day surgery under general anesthesia: a randomized controlled trial. Perioper Med (Lond). 2022 May 12;11(1):17. doi: 10.1186/s13741-022-00251-6.

  PMID: 35546414 DERIVED

MeSH Terms

Interventions

ramosetron

Study Officials

• Hyun-Jung Shin, MD., PhD.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun-Jung Shin, MD., PhD.

CONTACT

82317877499; hjshin.anesth@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 5, 2020
• Study Start: May 12, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: December 22, 2021

Record last verified: 2021-12

Locations

KR (1)