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

Phase 4 Study of Optimal Dose of Haloperidol

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.

Study Overview

• Status: Completed
• Conditions: Gynecological Disease
• Intervention / Treatment: Drug: Dexamethasone iv injection; Drug: Dexamethasone, haloperidol; Drug: Dexamethasone, haloperidol

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: dexamethasone; dexamethasone 5mg iv during anesthesia induction	Drug: Dexamethasone iv injection; Dexamethasone 5mg iv during anesthesia induction
ACTIVE_COMPARATOR: dexamethasone, haloperiol 1mg; dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia	Drug: Dexamethasone, haloperidol; dexamethasone + haloperidol 1mg; Drug: Dexamethasone, haloperidol; Active Comparator: dexamethasone + haloperidol 2mg
ACTIVE_COMPARATOR: dexamethasone + haloperidol 2mg; dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia	Drug: Dexamethasone, haloperidol; dexamethasone + haloperidol 1mg; Drug: Dexamethasone, haloperidol; Active Comparator: dexamethasone + haloperidol 2mg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Investigators: Principal Investigator: Y.E. Moon, MD, associate proffesor

Publications and helpful links

General Publications

• Joo J, Park YG, Baek J, Moon YE. Haloperidol dose combined with dexamethasone for PONV prophylaxis in high-risk patients undergoing gynecological laparoscopic surgery: a prospective, randomized, double-blind, dose-response and placebo-controlled study. BMC Anesthesiol. 2015 Jul 8;15:99. doi: 10.1186/s12871-015-0081-1.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): May 1, 2013

Study Registration Dates

• First Submitted: July 4, 2012
• First Submitted That Met QC Criteria: July 10, 2012
• First Posted (ESTIMATE): July 12, 2012

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: female; patient-controlled analgesia; non-smoker; IV PCA
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine Antagonists; Anti-Dyskinesia Agents; Dexamethasone; Dexamethasone acetate; BB 1101; Haloperidol; Haloperidol decanoate
• Other Study ID Numbers: haloperidol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO