Text Size

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.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01007500
First received: November 3, 2009
Last updated: October 6, 2010
Last verified: October 2010
History of Changes
  Purpose

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
Nausea
Vomiting
 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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007500

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

No publications provided

Responsible Party: Shim, Yon Hee/associate professor, Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Reseach Institute, Yonsei University College of Medicine
ClinicalTrials.gov 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, Welfare and Family Affairs

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

ClinicalTrials.gov processed this record on May 21, 2013