NCT01806948

Brief Summary

We randomized patients who received laparoscopic surgery for benign gynecologic disease into double dose (Experimental Group) or single dose (Control Group) of antiemetics. We compared the degree of postoperative nausea and vomiting in experimental and control groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

1.5 years

First QC Date

March 6, 2013

Last Update Submit

March 19, 2016

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • Complete Response Rate

    The percentage of patients who experienced neither nausea nor vomiting within 24 hours after surgery

    Postoperative 24 hours

Study Arms (2)

Control

PLACEBO COMPARATOR

Single dose of antiemetics. Specifically, Ramosetron 0.3 mg will be intravenously injected when surgery is ended. Additionally, placebo will be intravenously injected at 4 hours after surgery.

Drug: Ramosetron

Experimental

EXPERIMENTAL

Double dose of antiemetics. Specifically, Ramosetron 0.3 mg will be intravenously injected when surgery is ended. Additionally, Ramosetron 0.3 mg will be intravenously injected at 4 hours after surgery.

Drug: Ramosetron

Interventions

RamosetronDRUG
ControlExperimental

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Laparoscopy for benign gynecologic disease

You may not qualify if:

  • Vomiting within 24 hours before surgery
  • Not using patient controlled analgesics postoperatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463707, South Korea

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

ramosetron

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Design

Study Type
interventional
Phase
phase 2
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
Professor

Study Record Dates

First Submitted

March 6, 2013

First Posted

March 7, 2013

Study Start

April 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 22, 2016

Record last verified: 2016-03

Locations

KR(1)