N/A
Completed N=150
Optimal Haloperidol Dose for Postoperative Nausea and Vomiting Prevention in High-risk Patients
Gynecological Disease
Source: ClinicalTrials.gov NCT01639599 ↗
Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Incidence of Postoperative Nausea and Vomiting — 21; 11; 10 participants
Summary
Low-dose haloperidol is known to be effective for the treatment of postoperative nausea and vomiting (PONV). However, precise dose-response studies have not been completed, especially in patients at high risk for PONV who require combination therapy. This study sought to identify the optimal dose of haloperidol that could be combined with dexamethasone without adverse effects in high-risk PONV patients receiving intravenous patient-controlled anesthesia (IV PCA) after gynecological laparoscopic surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Postoperative Nausea and Vomiting |
21; 11; 10 | — |
| SECONDARY Incidence of Extrapyramidal Symptoms |
0; 0; 0 | — |
| SECONDARY Incidence of Cardiac Arrhythmia |
0; 0; 0 | — |
| SECONDARY Sedation Change in Recovery Room |
4.6; 4.7; 5.5; 4.4; 4.4; 5.0 | — |
Eligibility Criteria
Inclusion Criteria
- ASA physical status I or II women
- Aged 20 65 years, and scheduled for gynecologic laparoscopic surgery and IV patient-controlled analgesia (PCA) for postoperative pain control.
Exclusion Criteria
- Known allergy or intolerance to the study drug
- History of cardiac arrhythmia
- Psychiatric illness
- Chronic treatment with a dopamine antagonist
- Use of opioids or steroids within one week of surgery
- Use of antiemetic within 24 hours before the study
- No ability to use the PCA device
- Gastrointestinal, renal, or hepatic disease
- Insulin-dependent diabetes or obesity with a body mass index > 35 kg/m2.
Data sourced from ClinicalTrials.gov (NCT01639599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.