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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

Page last updated: August 23, 2015

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