Clinical trial NCT02143531: Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The success of the anti-emetic administered in treating the postoperative nausea and vomiting (PONV)
timeFrame: during the first hour postoperatively
Secondary outcomes:
measure: Severity of postoperative nausea and vomiting (PONV)
timeFrame: during the first 24 hours postoperatively
measure: Recurrence of postoperative nausea and vomiting (PONV)
timeFrame: during first 24 hours postoperatively
measure: Side effects in PACU
timeFrame: 1 hour postoperatively
measure: Patient satisfaction
timeFrame: 24 hours after surgery
measure: Rescue anti-emetic
timeFrame: during the first 24 hours postoperatively
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Marie Aouad
Study officials:
affiliation: American Univesity of Beirut Medical Center
name: Marie Aouad, MD
role: PRINCIPAL_INVESTIGATOR
References: