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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01013012
First Posted: November 13, 2009
Last Update Posted: February 3, 2012
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.
Information provided by (Responsible Party):
Yonsei University
  Purpose
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 Intervention Phase
Nausea Vomiting Drug: ramosetron with saline Drug: ramosetron with dexamethasone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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


Enrollment: 94
Study Start Date: January 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01013012     History of Changes
Other Study ID Numbers: 4-2007-0388
First Submitted: November 12, 2009
First Posted: November 13, 2009
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:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
Dexamethasone
Ramosetron
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
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