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

NCT02744508 | Completed

• 1 other identifier: 4-2015-0232
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Surgery

Keywords

palonosetron, dexamethasone, PONV (postoperative nausea and vomiting)

Outcome Measures

Primary Outcomes (1)

• incidence of clinically significant PONV with PONV impact scale

  72 hours

Study Arms (2)

P group

ACTIVE COMPARATOR

Palonosetron group

Drug: palonosetron

PD group

EXPERIMENTAL

Palonosetron and dexamethasone group

Drug: palonosetron with dexamethasone

Interventions

palonosetron DRUG

P group

palonosetron with dexamethasone DRUG

PD group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who are undergoing minor orthopedic surgery.
• IV patient controlled analgesia

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

Related 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. doi: 10.1093/oxfordjournals.bja.a013366.

  PMID: 10740540 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Vomiting

Interventions

Palonosetron; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 20, 2016
• Study Start: July 24, 2015
• Primary Completion: March 20, 2017
• Study Completion: March 20, 2017
• Last Updated: June 20, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)