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NCT01007500 Clinical Trial

Effect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic Surgery

Nausea Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01007500
Other study ID # 4-2009-0407
Secondary ID
Status Completed
Phase Phase 4
First received November 3, 2009
Last updated December 29, 2016
Start date September 2009
Est. completion date September 2010

Study information
Verified date December 2016
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug AdministrationKorea: Ministry for Health and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 123
Est. completion date September 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients undergoing video-assisted thoracoscopic surgery

- Age 20-75

- American Society of Anesthesiologists physical status classification I or II

Exclusion Criteria:

- Antiemetic within 24 hrs

- Taking Steroids, Opioids within 1 week

- Active drug or alcohol abuse

- GI motility disorder, severe renal/ hepatic disease.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Severance Hospital, Yonsei University College of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of postoperative nausea and vomiting within 48 hrs after surgery No
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