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Effect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic Surgery

This study has been completed.
Information provided by:
Yonsei University Identifier:
First received: November 3, 2009
Last updated: October 6, 2010
Last verified: October 2010
The purpose of this study is to study the effect of dexamethasone combined with ondansetron on postoperative nausea and vomiting in patients with patient-controlled analgesia after video-assisted thoracoscopic surgery.

Condition Intervention Phase
Drug: Dexamethasone, Ondansetron
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Incidence of postoperative nausea and vomiting [ Time Frame: within 48 hrs after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Dexamethasone, Ondansetron

    Experimental: Dexamethasone 8 mg IV after induction of anesthesia, Ondansetron 4 mg IV at the end of surgery and 12 mg mix to intravenous patient controlled analgesia device.

    Active comparator: Ondansetron 4 mg IV at the end of surgery and 12 mg mix to intravenous patient controlled analgesia device.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients undergoing video-assisted thoracoscopic surgery
  • Age 20-75
  • American Society of Anesthesiologists physical status classification I or II

Exclusion Criteria:

  • Antiemetic within 24 hrs
  • Taking Steroids, Opioids within 1 week
  • Active drug or alcohol abuse
  • GI motility disorder, severe renal/ hepatic disease.
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Please refer to this study by its identifier: NCT01007500

Korea, Republic of
Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Shim, Yon Hee/associate professor, Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Reseach Institute, Yonsei University College of Medicine Identifier: NCT01007500     History of Changes
Other Study ID Numbers: 4-2009-0407 
Study First Received: November 3, 2009
Last Updated: October 6, 2010
Health Authority: Korea: Food and Drug Administration
Korea: Ministry for Health and Welfare

Keywords provided by Yonsei University:
Postoperative nausea and vomiting after video-assisted thoracoscopic surgery

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
Dexamethasone 21-phosphate
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
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents processed this record on October 28, 2016