Effect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic 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: NCT01007500
Recruitment Status : Completed
First Posted : November 4, 2009
Last Update Posted : December 30, 2016
Information provided by:
Yonsei University

Brief Summary:
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 or disease Intervention/treatment Phase
Nausea Vomiting Drug: Dexamethasone Drug: Ondansetron Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : September 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
Experimental: Group Dexamethasone Drug: Dexamethasone
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: Group Ondansetron Drug: Ondansetron
Active comparator: Ondansetron 4 mg IV at the end of surgery and 12 mg mix to intravenous patient controlled analgesia device.

Primary Outcome Measures :
  1. Incidence of postoperative nausea and vomiting [ Time Frame: within 48 hrs after surgery ]

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01007500

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

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
First Posted: November 4, 2009    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016

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
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
Neurotransmitter Agents