Effect of Ramosetron on Post-discharge Nausea and Vomiting | NCT03409835

Studies
Effect of Ramosetron on Post-discharge Nausea and Vomiting

NCT03409835

Sponsor

Seoul National University Bundang Hospital

Status

Unknown status

Last Update Posted

Apr 20, 2018Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Hysteroscopy

Interventions

Ramosetron
Normal saline

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Actual

Primary Completion Date

Feb 2019Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

Jan 9, 2018

First Submission Date that Met QC Criteria

Jan 18, 2018

First Posted Date

Jan 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2018

Last Update Posted Date

Apr 20, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyo-Seok Na, Principle investigator, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ramosetron	Experimental		Drug: Ramosetron
Control	Placebo Comparator		Drug: Normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ramosetron	Drug	Ramosetron 0.3 mg is administered after induction of general anesthesia.	Ramosetron

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
The change of postoperative pain score	Score range is from 0 to 10.	Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
The change in the number of postoperative administration of rescue analgesic drug

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hyo-Seok Na	Contact	1087012913		hsknana@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National Univ. Bundang Hospital	Recruiting	Seongnam-si	Gyeonggi-do	463-707	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
C071315	ramosetron
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided