Back to resultsComparison of Palonosetron Versus Combination of Palonosetron and Dexamethasone for Preventing Postoperative Vomiting in Patients Receiving Fentanyl by Patient-controlled Analgesia After Minor Orthopedic Surgery
Primary Purpose
Orthopedic Surgery
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
palonosetron
palonosetron with dexamethasone
Sponsored by
About this trial
This is an interventional prevention trial for Orthopedic Surgery focused on measuring palonosetron, dexamethasone, PONV (postoperative nausea and vomiting)
Eligibility Criteria
Inclusion Criteria:
- patients who are undergoing minor orthopedic surgery.
- IV patient controlled analgesia
Exclusion Criteria:
- 1. minority (0~19 year)
- patients who are belongs to ASA class 3 or more, and have underlying complicated cardiovascular or psychological disease.
- Steroid medication
- Diabetes Mellitus medication
Sites / Locations
- Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
P group
PD group
Arm Description
Palonosetron group
Palonosetron and dexamethasone group
Outcomes
Primary Outcome Measures
incidence of clinically significant PONV with PONV impact scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02744508
Brief Title
Comparison of Palonosetron Versus Combination of Palonosetron and Dexamethasone for Preventing Postoperative Vomiting in Patients Receiving Fentanyl by Patient-controlled Analgesia After Minor Orthopedic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 24, 2015 (Actual)
Primary Completion Date
March 20, 2017 (Actual)
Study Completion Date
March 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Postoperative nausea and vomiting (PONV) is related with extended hospital day and risk factor of aspiration pneumonia. Postoperative patient controlled intravenous analgesia is related with postoperative nausea and vomiting. Selective 5-HT3 antagonist, Palonosetron, is the most recent medication for prevention of PONV. Purpose of our study is comparison of PONV preventive effect of palonosetron and combination of palonosetron and dexamethasone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Surgery
Keywords
palonosetron, dexamethasone, PONV (postoperative nausea and vomiting)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P group
Arm Type
Active Comparator
Arm Description
Palonosetron group
Arm Title
PD group
Arm Type
Experimental
Arm Description
Palonosetron and dexamethasone group
Intervention Type
Drug
Intervention Name(s)
palonosetron
Intervention Type
Drug
Intervention Name(s)
palonosetron with dexamethasone
Primary Outcome Measure Information:
Title
incidence of clinically significant PONV with PONV impact scale
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients who are undergoing minor orthopedic surgery.
IV patient controlled analgesia
Exclusion Criteria:
1. minority (0~19 year)
patients who are belongs to ASA class 3 or more, and have underlying complicated cardiovascular or psychological disease.
Steroid medication
Diabetes Mellitus medication
Facility Information:
Facility Name
Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
10740540
Citation
Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
Results Reference
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Comparison of Palonosetron Versus Combination of Palonosetron and Dexamethasone for Preventing Postoperative Vomiting in Patients Receiving Fentanyl by Patient-controlled Analgesia After Minor Orthopedic Surgery
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