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

NCT02143531 | Completed Phase 4

• 1 other identifier: ANES.MA 09
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Severity of postoperative nausea and vomiting (PONV)

  during the first 24 hours postoperatively

• Recurrence of postoperative nausea and vomiting (PONV)

  during first 24 hours postoperatively

• Side effects in PACU

  1 hour postoperatively

• Patient satisfaction

  24 hours after surgery

• Rescue anti-emetic

  during the first 24 hours postoperatively

Study Arms (2)

Group I

ACTIVE COMPARATOR

Patients will receive 4 mg of Ondansetron IV upon occurrence of nausea or vomiting

Drug: 4 mg of Ondansetron IV

Group II

ACTIVE COMPARATOR

Patients will receive 1mg of Haloperidol IV upon occurrence of nausea or vomiting

Drug: 1mg of Haloperidol IV

Interventions

4 mg of Ondansetron IV DRUG

Group I

1mg of Haloperidol IV DRUG

Group II

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80
• ASA class I, II, and III
• undergoing elective surgery under general anesthesia

You may not qualify if:

• Patients with history of arrhythmias, QTc prolongation or allergies to the study drugs will be excluded from the study.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

Marie Aouad

Beirut, Lebanon

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Marie Aouad, MD

  American Univesity of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Specialty

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 21, 2014
• Study Start: September 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

LE (1)