NCT01639599

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

Phase 4 Study of Optimal Dose of Haloperidol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: The Catholic University of Korea · Academic / Other
• Sex: Female
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Gynecological Disease

Interventions

Type	Name	Description
DRUG	Dexamethasone iv injection	Dexamethasone 5mg iv during anesthesia induction
DRUG	Dexamethasone, haloperidol	dexamethasone + haloperidol 1mg
DRUG	Dexamethasone, haloperidol	Active Comparator: dexamethasone + haloperidol 2mg

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-12-01
• Completion: 2013-05-01
• First posted: 2012-07-12
• Last updated: 2020-09-09
• Results posted: 2020-08-24