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NCT Number: NCT02143531

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Marie Aouad

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

4 mg of Ondansetron IV

Drug

1mg of Haloperidol IV

Drug

Primary outcomes

  1. The success of the anti-emetic administered in treating the postoperative nausea and vomiting (PONV)

    Time frame: 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 outcomes

  1. Severity of postoperative nausea and vomiting (PONV)

    Time frame: during the first 24 hours postoperatively

    Investigators will ask patients to grade the severity of their nausea episodes using the following scale:

    • No nausea; 1. mild ; 2. Discomforting; 3. Distressing; 4. Horrible; 5. Worst possible

  2. Recurrence of postoperative nausea and vomiting (PONV)

    Time frame: during first 24 hours postoperatively

  3. Side effects in PACU

    Time frame: 1 hour postoperatively

    Headache, Dizzines / Vertigo, Restlessness, Nystagmus or other extra-pyramidal symptoms, Sedation highest score, Pain highest score, QT prolongation

  4. Patient satisfaction

    Time frame: 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:

    • Excellent; 2. Good; 3. Fair; 4. Bad

  5. Rescue anti-emetic

    Time frame: during the first 24 hours postoperatively

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
May 21, 2014
Registry last updated
May 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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