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Effect of Ramosetron on Post-discharge Nausea and Vomiting

Primary Purpose

Hysteroscopy

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ramosetron
Normal saline
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hysteroscopy

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National Univ. Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ramosetron

Control

Arm Description

Outcomes

Primary Outcome Measures

The change in the occurrence of postoperative nausea
The change in the occurrence of postoperative vomiting

Secondary Outcome Measures

The change of postoperative pain score
Score range is from 0 to 10.
The change in the number of postoperative administration of rescue analgesic drug
The change in the number of postoperative administration of rescue antiemetic drug
The change of patient's satisfaction score
Score range is from 0 to 10.

Full Information

First Posted
January 9, 2018
Last Updated
April 18, 2018
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03409835
Brief Title
Effect of Ramosetron on Post-discharge Nausea and Vomiting
Official Title
Effect of Ramosetron on Post-discharge Nausea and Vomiting in Patients Undergoing Gynecologic Surgery Through a Day-surgery Center
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysteroscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ramosetron
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ramosetron
Intervention Description
Ramosetron 0.3 mg is administered after induction of general anesthesia.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Normal saline 2 ml is administered after induction of general anesthesia.
Primary Outcome Measure Information:
Title
The change in the occurrence of postoperative nausea
Time Frame
Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
Title
The change in the occurrence of postoperative vomiting
Time Frame
Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
Secondary Outcome Measure Information:
Title
The change of postoperative pain score
Description
Score range is from 0 to 10.
Time Frame
Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
Title
The change in the number of postoperative administration of rescue analgesic drug
Time Frame
Postoperative 30 minute and 3 hour
Title
The change in the number of postoperative administration of rescue antiemetic drug
Time Frame
Postoperative 30 minute and 3 hour
Title
The change of patient's satisfaction score
Description
Score range is from 0 to 10.
Time Frame
Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyo-Seok Na
Phone
1087012913
Email
hsknana@gmail.com
Facility Information:
Facility Name
Seoul National Univ. Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyo-Seok Na
Phone
1087012913
Email
hsknana@gmail.com

12. IPD Sharing Statement

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Effect of Ramosetron on Post-discharge Nausea and Vomiting

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