NCT01013012

Brief Summary

The purpose of this study is to study the efficacy of dexamethasone added to ramosetron for preventing postoperative nausea and vomiting in highly susceptible patients following spine surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_4

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
Last Updated

February 3, 2012

Status Verified

February 1, 2012

Enrollment Period

10 months

First QC Date

November 12, 2009

Last Update Submit

February 2, 2012

Conditions

NauseaVomiting

Keywords

highly susceptible patients following spine surgery

Outcome Measures

Primary Outcomes (1)

  • the incidence of postoperative nausea and vomiting(PONV)

    incidence of overall postoperative nausea and vomiting (PONV) between combination of ramosetron and dexamethasone and ramosetron alone in highly susceptible patients

    After spinal surgery

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A : saline 1 ml + ramosetron 6μg/kg

Drug: ramosetron with saline

Group B

EXPERIMENTAL

Group B : dexamethasone 4 mg + ramosetron 6μg/kg

Drug: ramosetron with dexamethasone

Interventions

ramosetron with salineDRUG

Group A : saline 1 ml, ramosetron 6μg/kg

Group A
ramosetron with dexamethasoneDRUG

Group B : dexamethasone 4 mg, ramosetron 6μg/kg

Group B

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females
  • Ages 18 to 65 years old

You may not qualify if:

  • Patients who is taking steroid or who had been treated for the gastrointestinal disease
  • Patients who have troubles with the kidney or liver
  • Patients transferring to the ICU after the surgery
  • overfat patients
  • Patients who had taken antiemetics within 24 hours before the surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NauseaVomiting

Interventions

ramosetronSodium ChlorideDexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2009

First Posted

November 13, 2009

Study Start

January 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

February 3, 2012

Record last verified: 2012-02