Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting

NCT ID: NCT02143531

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2012-08-31

Brief 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.

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.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group I

Patients will receive 4 mg of Ondansetron IV upon occurrence of nausea or vomiting

Group Type: ACTIVE_COMPARATOR

4 mg of Ondansetron IV

Intervention Type: DRUG

Group II

Patients will receive 1mg of Haloperidol IV upon occurrence of nausea or vomiting

Group Type: ACTIVE_COMPARATOR

1mg of Haloperidol IV

Intervention Type: DRUG

Interventions

4 mg of Ondansetron IV

Intervention Type: DRUG

1mg of Haloperidol IV

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dr. Marie Awad

Professor of Clinical Specialty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie Aouad, MD

Role: PRINCIPAL_INVESTIGATOR

American Univesity of Beirut Medical Center

Locations

Marie Aouad

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

ANES.MA 09

Identifier Type: -

Identifier Source: org_study_id