Efficacy of Dexamethasone Added to Ramosetron for Preventing Postoperative Nausea and Vomiting in Highly Susceptible Patients Following Spine Surgery

NCT ID: NCT01013012

Last Updated: 2012-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nausea Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group A

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

Group Type ACTIVE_COMPARATOR

ramosetron with saline

Intervention Type DRUG

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

Group B

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

Group Type EXPERIMENTAL

ramosetron with dexamethasone

Intervention Type DRUG

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

Interventions

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ramosetron with saline

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

Intervention Type DRUG

ramosetron with dexamethasone

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Females
* Ages 18 to 65 years old

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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4-2007-0388

Identifier Type: -

Identifier Source: org_study_id

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