Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting
Information source: American University of Beirut Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Nausea and Vomiting
Intervention: 4 mg of Ondansetron IV (Drug); 1mg of Haloperidol IV (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: American University of Beirut Medical Center Official(s) and/or principal investigator(s):
Marie Aouad, MD, Principal Investigator, Affiliation: American Univesity of Beirut Medical Center
Summary
This study aims to prove that at a dose of 1 mg Haloperidol possesses a high success rate in
controlling established postoperative nausea and vomiting (PONV) in the first 24 hours
following administration similar to the standard of care ondansetron 4 mg.
Clinical Details
Official title: Intravenous Haloperidol Versus Ondansetron for Treatment of Established Nausea and Vomiting in Patients Undergoing Surgery With General Anesthesia: A Randomized Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The success of the anti-emetic administered in treating the postoperative nausea and vomiting (PONV)
Secondary outcome: Severity of postoperative nausea and vomiting (PONV)Recurrence of postoperative nausea and vomiting (PONV) Side effects in PACU Patient satisfaction Rescue anti-emetic
Detailed description:
Patients undergoing surgery under general anesthesia may experience several complications in
their postoperative period. Nausea and vomiting are some of the more common of these
complications. Several medications can be used for prevention of these specific
complications, but treatment remains more cost-efficient.
Haloperidol is anti-psychotic which, at low doses, can prevent the occurrence of nausea and
vomiting. Its usefulness for prophylaxis has been demonstrated in several studies. However,
its use for treating established postoperative nausea and vomiting (PONV) has not been
properly studied.
In a prospective randomized clinical trial involving adult patients undergoing elective
surgery under general anesthesia, investigators will enroll 120 patients, and compare the
effect of a dose of 1 mg Haloperidol versus Ondansetron 4 mg and document the varying
degrees of success in treating nausea and vomiting as well as possible side effects.
Investigators expect to observe that Haloperidol is as effective as treatment with
Ondansetron.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients aged 18-80
- ASA class I, II, and III
- undergoing elective surgery under general anesthesia
Exclusion Criteria:
- Patients with history of arrhythmias, QTc prolongation or allergies to the study
drugs will be excluded from the study.
Locations and Contacts
Marie Aouad, Beirut, Lebanon
Additional Information
Starting date: September 2008
Last updated: May 21, 2014
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