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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01013012
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : February 3, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Nausea Vomiting Drug: ramosetron with saline Drug: ramosetron with dexamethasone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Group A
Group A : saline 1 ml + ramosetron 6μg/kg
Drug: ramosetron with saline
Group A : saline 1 ml, ramosetron 6μg/kg

Experimental: Group B
Group B : dexamethasone 4 mg + ramosetron 6μg/kg
Drug: ramosetron with dexamethasone
Group B : dexamethasone 4 mg, ramosetron 6μg/kg

Primary Outcome Measures :
  1. the incidence of postoperative nausea and vomiting(PONV) [ Time Frame: After spinal surgery ]
    incidence of overall postoperative nausea and vomiting (PONV) between combination of ramosetron and dexamethasone and ramosetron alone in highly susceptible patients

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Responsible Party: Yonsei University Identifier: NCT01013012     History of Changes
Other Study ID Numbers: 4-2007-0388
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: February 2012

Keywords provided by Yonsei University:
highly susceptible patients following spine surgery

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents