Effect of Ramosetron on Post-discharge Nausea and Vomiting

Effect of Ramosetron on Post-discharge Nausea and Vomiting in Patients Undergoing Gynecologic Surgery Through a Day-surgery Center

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 or vomiting occurs. Thus, It is necessary to prevent these symptoms beforehand. Patients who underwent gynecologic surgery will be treated with prophylactic ramosetron to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.

Study Overview

• Status: Unknown
• Conditions: Hysteroscopy
• Intervention / Treatment: Drug: Ramosetron; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of, 463-707
      • Recruiting
      • Seoul National Univ. Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients who undergo hysteroscopic surgery and are discharged on the day of surgery.

Exclusion Criteria:

• American Society of Anesthesiologists physical statue 3 or more
• Planned admission after surgery
• Intravenous anesthesia
• During chemotherapy
• Pregnancy or breastfeeding
• Abnormal liver or kidney function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Drug: Normal saline; Normal saline 2 ml is administered after induction of general anesthesia.
Experimental: Ramosetron	Drug: Ramosetron; Ramosetron 0.3 mg is administered after induction of general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of postoperative pain score	Score range is from 0 to 10.	Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
The change in the number of postoperative administration of rescue analgesic drug		Postoperative 30 minute and 3 hour
The change in the number of postoperative administration of rescue antiemetic drug		Postoperative 30 minute and 3 hour
The change of patient's satisfaction score	Score range is from 0 to 10.	Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2018
• Last Update Submitted That Met QC Criteria: April 18, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Ramosetron
• Other Study ID Numbers: PDNV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No