Effect of Ramosetron on Post-discharge Nausea and Vomiting

NCT03409835 — Not applicable, Unknown, 100 participants, Seoul National University Bundang Hospital

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

Registry	NCT03409835
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	100 (Estimated)
Sponsor	Seoul National University Bundang Hospital (Other)
Conditions	Hysteroscopy
Interventions	Ramosetron, Normal saline (Drug)
Dates	start 2018-03-01, primary completion 2019-02-01 (estimated), completion 2019-06-01 (estimated), first posted 2018-01-24, last updated 2018-04-20
Locations	1 site in South Korea

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Ramosetron	Experimental	Drug: Ramosetron
Control	Placebo comparator	Drug: Normal saline

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

+Outcome measures

Primary outcomes

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

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]
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.

+Eligibility

Sex: Female, ages: 20 Years to 60 Years

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

+Locations (1)

Facility	City	Country	Status
Seoul National Univ. Bundang Hospital	Seongnam-si, Gyeonggi-do	South Korea	Recruiting

My Notes

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