NCT01007500

Brief Summary

The purpose of this study is to study the effect of dexamethasone combined with ondansetron on postoperative nausea and vomiting in patients with patient-controlled analgesia after video-assisted thoracoscopic surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

December 30, 2016

Status Verified

December 1, 2016

Enrollment Period

10 months

First QC Date

November 3, 2009

Last Update Submit

December 29, 2016

Conditions

NauseaVomiting

Keywords

Postoperative nausea and vomiting after video-assisted thoracoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative nausea and vomiting

    within 48 hrs after surgery

Study Arms (2)

Group Dexamethasone

EXPERIMENTAL
Drug: Dexamethasone

Group Ondansetron

ACTIVE COMPARATOR
Drug: Ondansetron

Interventions

DexamethasoneDRUG

Experimental: Dexamethasone 8 mg IV after induction of anesthesia, Ondansetron 4 mg IV at the end of surgery and 12 mg mix to intravenous patient controlled analgesia device.

Group Dexamethasone
OndansetronDRUG

Active comparator: Ondansetron 4 mg IV at the end of surgery and 12 mg mix to intravenous patient controlled analgesia device.

Group Ondansetron

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing video-assisted thoracoscopic surgery
  • Age 20-75
  • American Society of Anesthesiologists physical status classification I or II

You may not qualify if:

  • Antiemetic within 24 hrs
  • Taking Steroids, Opioids within 1 week
  • Active drug or alcohol abuse
  • GI motility disorder, severe renal/ hepatic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

NauseaVomitingPostoperative Nausea and Vomiting

Interventions

DexamethasoneOndansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2009

First Posted

November 4, 2009

Study Start

September 1, 2009

Primary Completion

July 1, 2010

Study Completion

September 1, 2010

Last Updated

December 30, 2016

Record last verified: 2016-12

Locations

KR(1)