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

NCT ID: NCT02744508

Last Updated: 2018-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-24

Study Completion Date

2017-03-20

Brief Summary

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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.

Detailed Description

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Conditions

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Orthopedic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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P group

Palonosetron group

Group Type ACTIVE_COMPARATOR

palonosetron

Intervention Type DRUG

PD group

Palonosetron and dexamethasone group

Group Type EXPERIMENTAL

palonosetron with dexamethasone

Intervention Type DRUG

Interventions

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palonosetron

Intervention Type DRUG

palonosetron with dexamethasone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 10740540 (View on PubMed)

Other Identifiers

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4-2015-0232

Identifier Type: -

Identifier Source: org_study_id

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