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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intravenous Haloperidol Versus Ondansetron for Treatment of Established Nausea and Vomiting in Patients Undergoing Surgery With General Anesthesia: A Randomized Clinical Trial

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: 4 mg of Ondansetron IV
* Drug: 1mg of Haloperidol IV


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>Patients will receive 4 mg of Ondansetron IV upon occurrence of nausea or vomiting | Drug: 4 mg of Ondansetron IV<br> <br> |
| Active Comparator: Group II<br>Patients will receive 1mg of Haloperidol IV upon occurrence of nausea or vomiting | Drug: 1mg of Haloperidol IV<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | during the first hour postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | during the first 24 hours postoperatively | 
| Recurrence of postoperative nausea and vomiting (PONV) |  | 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 | 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 | 24 hours after surgery | 
| Rescue anti-emetic |  | during the first 24 hours postoperatively |