ClinicalTrials.gg
Status unknownNCT03409835Updated Apr 20, 2018

Effect of Ramosetron on Post-discharge Nausea and Vomiting

An interventional study of Ramosetron and Normal saline in Hysteroscopy, sponsored by Seoul National University Bundang Hospital. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-04-20.

Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Hysteroscopy
03

In context

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 377 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • physical statue 3 or more
  • Planned admission after surgery
  • Intravenous anesthesia
  • During chemotherapy
  • Pregnancy or breastfeeding
  • Abnormal liver or kidney function
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Ramosetron

    Drug: Ramosetron

  • Placebo comparator
    Control

    Drug: Normal saline

Interventions

  • Ramosetron 0.3 mg is administered after induction of general anesthesia.

  • DrugNormal saline

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

06

What researchers measure

Primary outcomes

  1. The change in the occurrence of postoperative nausea

    Time frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

  2. The change in the occurrence of postoperative vomiting

    Time frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

Secondary outcomes

  1. The change of postoperative pain score

    Score range is from 0 to 10.

    Time frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

  2. The change in the number of postoperative administration of rescue analgesic drug

    Time frame: Postoperative 30 minute and 3 hour

  3. The change in the number of postoperative administration of rescue antiemetic drug

    Time frame: Postoperative 30 minute and 3 hour

  4. The change of patient's satisfaction score

    Score range is from 0 to 10.

    Time frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

07

Study locations

1 of 1 sites recruiting
  • Seoul National Univ. Bundang Hospital
    Seongnam, Gyeonggi 463-707, Korea, Republic of
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2018 (actual). Primary completion is estimated for Feb 2019, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2018
First posted
Jan 24, 2018
StartActual
Mar 1, 2018
Primary completionEst.
Feb 2019
CompletionEst.
Jun 2019
Last update
Apr 20, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03409835
Responsible party
Hyo-Seok Na (Principle investigator, Seoul National University Bundang Hospital) — Principal investigator
First posted
Jan 24, 2018
Start date
Mar 1, 2018
Primary completion
Feb 2019 (estimated)
Completion
Jun 2019 (estimated)
Last update
Apr 20, 2018

Study contacts

Hyo-Seok Na
Contact
hsknana@gmail.com
1087012913

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ramosetron

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