Dose-ranging Study of Ramosetron for the Prevention of Na... | NCT02478645

Studies
Dose-ranging Study of Ramosetron for the Prevention of Nausea and Vomiting After Gynecologic Laparoscopic Surgery

NCT02478645

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Jan 25, 2017Estimated

Enrollment

177Actual

Phase

Phase 4

Conditions

Postoperative Nausea and Vomiting

Interventions

ramosetron 0.3
ramosetron 0.45
ramosetron 0.6

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

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 19, 2015Actual

Primary Completion Date

Feb 6, 2016Actual

Completion Date

Feb 6, 2016Actual

First Submitted Date

Jun 18, 2015

First Submission Date that Met QC Criteria

Jun 18, 2015

First Posted Date

Jun 23, 2015Estimated

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

Jan 24, 2017

Last Update Posted Date

Jan 25, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Many patients receiving opioid based analgesia after gynecologic laparoscopic surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists. Although a high dose of ramosetron can cause adverse effects such as headache or dizziness, the minimal effective dose of ramosetron in a high-risk patients is unknown. The aim of this study is to determine the effective dose of ramosetron for prophylaxis of PONV in a high-risk patients receiving intravenous opioid-based patient-controlled analgesia after gynecological laparoscopic surgery.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

177Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
ramosetron 0.3	Experimental	Drug: ramosetron 0.3
ramosetron 0.45	Active Comparator	Drug: ramosetron 0.45
ramosetron 0.6	Active Comparator	Drug: ramosetron 0.6

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ramosetron 0.3	Drug	The ramosetron 0.3 group receives ramosetron 0.3 mg at the end of surgery.	ramosetron 0.3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative nausea and vomiting	incidence of nausea and vomiting during the first 48 h after surgery	within 48h after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅱ
patient scheduled for elective gynecological laparoscopic surgery.

Exclusion Criteria:

hepatorenal disease
BMI > 35 kg/m2
allergy to ramosetron
gastrointestinal disease
vomiting within 24h
administration of antiemetics or opioids within 24h
QT prolongation (QTc > 440ms)
pregnant
problem with communication

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu		Seoul	Seoul	120-752	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009325	Nausea

Browse Leaves

Not provided

Browse Branches

Not provided