Optimal Haloperidol Dose for Postoperative Nausea and Vomiting Prevention in High-risk Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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Female adults with three established PONV risk factors based on Apfel's score were randomised into one of three study groups. At the end of anaesthesia, groups H0, H1, and H2 were given intravenous (IV) saline, haloperidol 1 mg, and haloperidol 2 mg, respectively. All patients were given dexamethasone during the induction of anaesthesia. The overall early (0-2 h) and late (2-24 h) incidences of nausea, vomiting, rescue anti-emetic administration, pain, and adverse effects (cardiac arrhythmias and extrapyramidal effects) were assessed postoperatively. The sedation score was recorded in the postanaesthesia care unit (PACU).

Official Title
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Phase 4 Study of Optimal Dose of Haloperidol

Conditions
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Gynecological Disease

Intervention / Treatment
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* Drug: Dexamethasone iv injection
* Drug: Dexamethasone, haloperidol
* Drug: Dexamethasone, haloperidol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: dexamethasone<br>dexamethasone 5mg iv during anesthesia induction | Drug: Dexamethasone iv injection<br>* Dexamethasone 5mg iv during anesthesia induction<br>|
| Active Comparator: dexamethasone, haloperiol 1mg<br>dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia | Drug: Dexamethasone, haloperidol<br>* dexamethasone + haloperidol 1mg<br>|
| Active Comparator: dexamethasone + haloperidol 2mg<br>dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia | Drug: Dexamethasone, haloperidol<br>* Active Comparator: dexamethasone + haloperidol 2mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Postoperative Nausea and Vomiting | incidence of nausea, vomiting and requirement for rescue antiemetics | postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Extrapyramidal Symptoms |  | postoperative 24 hours | 
| Incidence of Cardiac Arrhythmia | cardiac arrhythmia on continuous standard lead EKG monitoring | postoperative 2 hours | 
| Sedation Change in Recovery Room | measurement of sedation change using a visual analogue scale (visual analogue scale; the minimum: 0 = widely awake and the maximum: 10 = maximally asleep) | postoperative 30, 60, 90, and 120 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-smoker, female, IV PCA, patient-controlled analgesia