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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03409835
Other study ID # PDNV
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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