Back to resultsEffect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic Surgery
Primary Purpose
Nausea, Vomiting
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexamethasone
Ondansetron
Sponsored by
About this trial
This is an interventional prevention trial for Nausea focused on measuring Postoperative nausea and vomiting after video-assisted thoracoscopic surgery
Eligibility 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.
Sites / Locations
- Severance Hospital, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group Dexamethasone
Group Ondansetron
Arm Description
Outcomes
Primary Outcome Measures
Incidence of postoperative nausea and vomiting
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01007500
Brief Title
Effect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
Keywords
Postoperative nausea and vomiting after video-assisted thoracoscopic surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Dexamethasone
Arm Type
Experimental
Arm Title
Group Ondansetron
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
Active comparator: Ondansetron 4 mg IV at the end of surgery and 12 mg mix to intravenous patient controlled analgesia device.
Primary Outcome Measure Information:
Title
Incidence of postoperative nausea and vomiting
Time Frame
within 48 hrs after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Severance Hospital, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic Surgery
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