Effect of Ramosetron on Post-discharge Nausea and Vomiting

Not Applicable

• Conditions: Hysteroscopy
• Interventions: Drug: Normal saline; Drug: Ramosetron

• Registration Number: NCT03409835
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-24
• Study Start: 2018-03-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-18
• Last Update Posted: 2018-04-20
• Primary Completion: 2019-02
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Normal saline	-
Ramosetron	Ramosetron	-

Primary Outcome Measures

Name	Time	Method
The change in the occurrence of postoperative vomiting	Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
The change in the occurrence of postoperative nausea	Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

Secondary Outcome Measures

Name	Time	Method
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	Postoperative 30 minute, 3 hour, 24 hour, and 48 hour	Score range is from 0 to 10.
The change of postoperative pain score	Postoperative 30 minute, 3 hour, 24 hour, and 48 hour	Score range is from 0 to 10.
The change in the number of postoperative administration of rescue analgesic drug	Postoperative 30 minute and 3 hour

Trial Locations

Locations (1)

Seoul National Univ. Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of