NCT01639599|CompletedResultsDMC
Optimal Haloperidol Dose for Postoperative Nausea and Vomiting Prevention in High-risk Patients
Phase 4 Study of Optimal Dose of Haloperidol
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Sponsor study identifier
interventional
150
0 countries
N/A
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
May 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
July 4, 2012
Actual (reported)July 12, 2012
Actual (reported)December 2012
Actual (reported)May 2013
Actual (reported)August 24, 2020
Actual (reported)Incidence of Postoperative Nausea and Vomiting
incidence of nausea, vomiting and requirement for rescue antiemetics
postoperative 24 hours
Incidence of Extrapyramidal Symptoms
postoperative 24 hours
Incidence of Cardiac Arrhythmia
postoperative 2 hours
Sedation Change in Recovery Room
postoperative 30, 60, 90, and 120 min
dexamethasone 5mg iv during anesthesia induction
dexamethasone 5mg iv during anesthesia induction \& haloperidol 1mg iv 30 min before end of anesthesia
dexamethasone 5mg iv during anesthesia induction \& haloperidol 2mg iv 30 min before end of anesthesia
dexamethasone + haloperidol 1mg
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Dexamethasone, haloperidol
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Dexamethasone, haloperidol
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordJoo 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.
Y.E. Moon, MD
associate proffesor
150 participants (actual enrollment reported by the registry).
First Submitted
July 4, 2012
First Posted
July 12, 2012
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Active Comparator: dexamethasone + haloperidol 2mg
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2012
Actual (reported)Study Completion
May 2013
Actual (reported)Last Updated
September 9, 2020
Results First Posted
August 24, 2020
Record last verified: 2020-08
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Source: ClinicalTrials.gov.
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