Postoperative Nausea and Vomiting
Conditions
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.
Interventions
DRUG4 mg of Ondansetron IV
DRUG1mg of Haloperidol IV
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Lebanon
Outcome results
None listed