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not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.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

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03

Who can participate

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

Inclusion criteria

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

Exclusion criteria

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
04

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

  • DrugRamosetron

    Ramosetron 0.3 mg is administered after induction of general anesthesia.

  • DrugNormal saline

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

05

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

06

Study locations

1 of 1 sites recruiting
  • Seoul National Univ. Bundang Hospital
    Seongnam, Gyeonggi 463-707, Korea, Republic of
    Recruiting
07

Registry details

Key details

Study ID
NCT03409835
Lead sponsor
Seoul National University Bundang Hospital
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 ↗

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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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