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

Phase 4

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: 4 mg of Ondansetron IV; Drug: 1mg of Haloperidol IV

• Registration Number: NCT02143531
• Lead Sponsor: American University of Beirut Medical Center

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.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-05
• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-21
• Last Update Submitted: 2014-05-21
• Last Update Posted: 2014-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	4 mg of Ondansetron IV	Patients will receive 4 mg of Ondansetron IV upon occurrence of nausea or vomiting
Group II	1mg of Haloperidol IV	Patients will receive 1mg of Haloperidol IV upon occurrence of nausea or vomiting

Primary Outcome Measures

Name	Time	Method
The success of the anti-emetic administered in treating the postoperative nausea and vomiting (PONV)	during the first hour postoperatively	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".

Secondary Outcome Measures

Name	Time	Method
Severity of postoperative nausea and vomiting (PONV)	during the first 24 hours postoperatively	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
Recurrence of postoperative nausea and vomiting (PONV)	during first 24 hours postoperatively
Side effects in PACU	1 hour postoperatively	Headache, Dizzines / Vertigo, Restlessness, Nystagmus or other extra-pyramidal symptoms, Sedation highest score, Pain highest score, QT prolongation
Patient satisfaction	24 hours after surgery	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
Rescue anti-emetic	during the first 24 hours postoperatively

Trial Locations

Locations (1)

Marie Aouad; 🇱🇧 Beirut, Lebanon