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

The Catholic University of Korea

Status: Completed

Conditions: Gynecological Disease

Treatments: Drug: Dexamethasone iv injection; Drug: Dexamethasone, haloperidol

Study type: Interventional

Funder types: Other

Identifiers

NCT01639599

haloperidol

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 150 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

dexamethasone

Placebo Comparator group

Description:

dexamethasone 5mg iv during anesthesia induction

Treatment:

Drug: Dexamethasone iv injection

dexamethasone, haloperiol 1mg

Active Comparator group

Description:

dexamethasone 5mg iv during anesthesia induction \& haloperidol 1mg iv 30 min before end of anesthesia

Treatment:

Drug: Dexamethasone, haloperidol

Drug: Dexamethasone, haloperidol

dexamethasone + haloperidol 2mg

Active Comparator group

Description:

dexamethasone 5mg iv during anesthesia induction \& haloperidol 2mg iv 30 min before end of anesthesia

Treatment:

Drug: Dexamethasone, haloperidol

Drug: Dexamethasone, haloperidol