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NCT02744508 Clinical Trial

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

Orthopedic Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02744508
Other study ID # 4-2015-0232
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 24, 2015
Est. completion date March 20, 2017

Study information
Verified date June 2018
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 202
Est. completion date March 20, 2017
Est. primary completion date March 20, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• palonosetron

• palonosetron with dexamethasone

Locations
Country Name City State
Korea, Republic of Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of clinically significant PONV with PONV impact scale 72 hours
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