Effect of Ramosetron on Post-discharge Nausea and Vomiting

Hysteroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03409835
• Other study ID #: PDNV
• Status: Recruiting
• Phase: N/A
• First received: January 9, 2018
• Last updated: April 18, 2018
• Start date: March 1, 2018
• Est. completion date: June 2019

Study information

• Verified date: April 2018
• Source: Seoul National University Bundang Hospital
• Contact: Hyo-Seok Na
• Phone: 1087012913
• Email: hsknana[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hysteroscopy
• Vomiting

Intervention

Drug:
• Ramosetron
Ramosetron 0.3 mg is administered after induction of general anesthesia.
• Normal saline
Normal saline 2 ml is administered after induction of general anesthesia.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univ. Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang 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 of postoperative pain score	Score range is from 0 to 10.	Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
Secondary	The change in the number of postoperative administration of rescue analgesic drug		Postoperative 30 minute and 3 hour
Secondary	The change in the number of postoperative administration of rescue antiemetic drug		Postoperative 30 minute and 3 hour
Secondary	The change of patient's satisfaction score	Score range is from 0 to 10.	Postoperative 30 minute, 3 hour, 24 hour, and 48 hour