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

American University of Beirut Medical Center120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Postoperative Nausea and Vomiting

Interventions

4 mg of Ondansetron IVDRUG

1mg of Haloperidol IVDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 (1)

Marie Aouad

Beirut, Lebanon

Outcomes

Primary Outcomes

The success of the anti-emetic administered in treating the postoperative nausea and vomiting (PONV)

Investigators will assess the success rate of the anti-emetic used: resolution of post-operative nausea and vomiting within 30 minutes from the adminstration of the anti-emetic will be considered "success".

Time frame: during the first hour postoperatively

Secondary Outcomes

Severity of postoperative nausea and vomiting (PONV)

Investigators will ask patients to grade the severity of their nausea episodes using the following scale: 0\. No nausea; 1. mild ; 2. Discomforting; 3. Distressing; 4. Horrible; 5. Worst possible

Time frame: during the first 24 hours postoperatively

Recurrence of postoperative nausea and vomiting (PONV)

Time frame: during first 24 hours postoperatively

Side effects in PACU

Headache, Dizzines / Vertigo, Restlessness, Nystagmus or other extra-pyramidal symptoms, Sedation highest score, Pain highest score, QT prolongation

Time frame: 1 hour postoperatively

Patient satisfaction

24 hours following surgery, investigators will ask patients to grade their satisfaction with the treatment of post-operative nausea and vomiting using the following scale: 1\. Excellent; 2. Good; 3. Fair; 4. Bad

Time frame: 24 hours after surgery

Rescue anti-emetic

Time frame: during the first 24 hours postoperatively

Data from ClinicalTrials.gov

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