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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT02744508

Collaborator

(none)

202

Enrollment

Location

Arms

19.9

Actual Duration (Months)

10.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Orthopedic Surgery	Drug: palonosetron Drug: palonosetron with dexamethasone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

202 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Actual Study Start Date :

Jul 24, 2015

Actual Primary Completion Date :

Mar 20, 2017

Actual Study Completion Date :

Mar 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: P group Palonosetron group	Drug: palonosetron
Experimental: PD group Palonosetron and dexamethasone group	Drug: palonosetron with dexamethasone

Arm

Intervention/Treatment

Active Comparator: P group

Palonosetron group

Drug: palonosetron

Experimental: PD group

Palonosetron and dexamethasone group

Drug: palonosetron with dexamethasone

Outcome Measures

Primary Outcome Measures

incidence of clinically significant PONV with PONV impact scale [72 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul		Korea, Republic of	03722