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:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01013012
First received: November 12, 2009
Last updated: February 2, 2012
Last verified: February 2012
  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: 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01013012     History of Changes
Other Study ID Numbers: 4-2007-0388
Study First Received: November 12, 2009
Last Updated: February 2, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
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

ClinicalTrials.gov processed this record on August 26, 2014