Clinical trial NCT01639599: Optimal Haloperidol Dose for Postoperative Nausea and Vomiting Prevention in High-risk Patients
Official title: Phase 4 Study of Optimal Dose of Haloperidol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecological Disease
Keywords: non-smoker
female
IV PCA
patient-controlled analgesia
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Postoperative Nausea and Vomiting
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: Incidence of Extrapyramidal Symptoms
timeFrame: postoperative 24 hours
measure: Incidence of Cardiac Arrhythmia
timeFrame: postoperative 2 hours
measure: Sedation Change in Recovery Room
timeFrame: postoperative 30, 60, 90, and 120 min
Other outcomes:
Locations:
Study officials:
affiliation: associate proffesor
name: Y.E. Moon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.