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

Phase 4

Completed

• Conditions: Nausea; Vomiting
• Interventions: Drug: ramosetron with saline; Drug: ramosetron with dexamethasone

• Registration Number: NCT01013012
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2009-11-12
• Study First Submitted QC: 2009-11-12
• Study First Posted: 2009-11-13
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-02
• Last Update Posted: 2012-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	ramosetron with saline	Group A : saline 1 ml + ramosetron 6μg/kg
Group B	ramosetron with dexamethasone	Group B : dexamethasone 4 mg + ramosetron 6μg/kg

Primary Outcome Measures

Name	Time	Method
the incidence of postoperative nausea and vomiting(PONV)	After spinal surgery	incidence of overall postoperative nausea and vomiting (PONV) between combination of ramosetron and dexamethasone and ramosetron alone in highly susceptible patients