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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143531
• Other study ID #: ANES.MA 09
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2014
• Last updated: May 21, 2014
• Start date: September 2008
• Est. completion date: August 2012

Study information

• Verified date: May 2014
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• 4 mg of Ondansetron IV

• 1mg of Haloperidol IV

Locations

Country	Name	City	State
Lebanon	Marie Aouad	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Recurrence of postoperative nausea and vomiting (PONV)		during first 24 hours postoperatively	No
Secondary	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	No
Secondary	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	No
Secondary	Rescue anti-emetic		during the first 24 hours postoperatively	No