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

Not Applicable

Completed

• Conditions: Gynecological Disease
• Interventions: Drug: Dexamethasone iv injection; Drug: Dexamethasone, haloperidol

• Registration Number: NCT01639599
• Lead Sponsor: The Catholic University of Korea

Brief 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).

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-07-04
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-12
• Primary Completion: 2012-12
• Study Completion: 2013-05
• Status Verified: 2020-08
• Results First Submitted: 2020-08-10
• Results First Submitted QC: 2020-08-10
• Results First Posted: 2020-08-24
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexamethasone	Dexamethasone iv injection	dexamethasone 5mg iv during anesthesia induction
dexamethasone, haloperiol 1mg	Dexamethasone, haloperidol	dexamethasone 5mg iv during anesthesia induction \& haloperidol 1mg iv 30 min before end of anesthesia
dexamethasone + haloperidol 2mg	Dexamethasone, haloperidol	dexamethasone 5mg iv during anesthesia induction \& haloperidol 2mg iv 30 min before end of anesthesia

Primary Outcome Measures

Name	Time	Method
Incidence of Postoperative Nausea and Vomiting	postoperative 24 hours	incidence of nausea, vomiting and requirement for rescue antiemetics

Secondary Outcome Measures

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