NCT03409835

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

11 months

First QC Date

January 9, 2018

Last Update Submit

April 18, 2018

Conditions

Hysteroscopy

Outcome Measures

Primary Outcomes (2)

  • 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 (4)

  • The change of postoperative pain score

    Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

  • 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

Study Arms (2)

Ramosetron

EXPERIMENTAL
Drug: Ramosetron

Control

PLACEBO COMPARATOR
Drug: Normal saline

Interventions

RamosetronDRUG

Ramosetron 0.3 mg is administered after induction of general anesthesia.

Ramosetron
Normal salineDRUG

Normal saline 2 ml is administered after induction of general anesthesia.

Control

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who undergo hysteroscopic surgery and are discharged on the day of surgery.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National Univ. Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Interventions

ramosetronSaline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Hyo-Seok Na

CONTACT

1087012913hsknana@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

January 9, 2018

First Posted

January 24, 2018

Study Start

March 1, 2018

Primary Completion

February 1, 2019

Study Completion

June 1, 2019

Last Updated

April 20, 2018

Record last verified: 2018-04

Locations

KR(1)