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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

Gender Influence on Torsadogenic Actions of Droperidol.

Clinicaltrials.gov identifier NCT03944681

Recruitment Status Recruiting

First Posted May 9, 2019

Last update posted September 10, 2020

Study Description

Brief summary:

Postoperative nausea and vomiting (PONV) is a quite common complication affecting patients undergoing general anesthesia. There are a few pharmacological agents of well known effectiveness in reducing the risk of PONV. One of them is droperidol, which is a butyrophenone derivant. It has been widely used for the prevention and treatment of PONV due to its high effectiveness and low cost. Though, droperidol has a relevant side effect, that is a repolarization prolongation. This can lead to life-threatening cardiac arrhythmias: polymorphic ventricular tachycardia (torsades de pointes, TdP) that can degenerate into ventricular fibrillation and cardiac arrest. This was a reason why in 2001 the FDA issued a "black box" warning on droperidol. Ever since papers focused on this problem have described the influence of small doses of droperidol on TdP genesis as weak. This could be explained by the fact, that QT/QTc (corrected QT) interval prolongation, which represents prolonged cardiac repolarization on ECG, is not the sole determinant of a drug's potential to cause arrhythmia. Another electrocardiographical marker of torsadogenic action is increased transmural dispersion of repolarization (TDR). TDR represents differences in the repolarization between myocardial "layers" (like epicardium, endocardium, myocardium cells). It is believed that the induction of QT/QTc lengthening must coexist with TDR increase at the same time to promote torsadogenic changes. It has been known, on the basis of research, that females have been more potent to torsadogenic actions of pharmacological agents than males. That could be related to estrogen influence on ECG parameters, which had been proven on animal model. It hasn't been investigated, whether gender is an important factor when considering droperidol's torsadogenic potential. The aim of this study is to answer a hypothesis, that women are more potent to torsadogenic actions of droperidol in comparison with men.

  • Condition or Disease:Arrhythmia, Droperidol
  • Intervention/Treatment: Drug: Droperidol Injectable Solution
  • Phase: N/A
Detailed Description


Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 70 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Supportive Care
  • Official Title: Gender Influence on Torsadogenic Actions of Droperidol Used as Postoperative Nausea and Vomiting Prophylaxis.
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020
Arms and interventions
Arm Intervention/treatment
Other: Droperidol group
Droperidol (Xomolix, Kyowa Kirin) 1.25 mg i.v. bolus
Drug: Droperidol Injectable Solution
An electrocardiogram analysis in: 5,10,15,20 minutes after injection of 1.25 mg of droperidol used as PONV prophylaxis.
Outcome Measures
  • Primary Outcome Measures: 1. QT and corrected QT interval time [ Time Frame: Change from baseline QT and corrected QT interval time at 5,10,15 and 20 minutes after administration of 1.25 mg droperidol ]
    measured in milliseconds
  • 2. Time interval between T wave peak and T wave end [ Time Frame: Change from baseline T peak - T end time at 5,10,15 and 20 minutes after administration of 1.25 mg droperidol. ]
    measured in milliseconds
Eligibility Criteria
  • Ages Eligible for Study: 18 to 45 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Inclusion Criteria:

- age between 18 and 45 years old

- ASA (American Society of Anaesthesiologists) physical status 1 and 2

Exclusion Criteria:

- lack of informed consent

- ASA (American Society of Anaesthesiologists) physical status 3 and more

- admittance of repolarisation affecting drugs like: antiarrhythmics (Williams group
I-IV), psychotropics, macrolides, antireflux drugs

- ischaemic heart disease

- cardiac failure NYHA (Hew York Heart Association) 1 and more

- congenital or acquired heart defects

- arrhythmias in anamnesis

- hormonal contraception,

- postmenopausal

- neoplasms

Contacts and Locations

Contact: Karol Broniecki, MD +48 58 726 02 87 k.broniecki@hotmail.com


Medical University of Gdansk

Sponsors and Collaborators

Medical University of Gdansk


Principal Investigator: Radoslaw Owczuk, Professor Medical University of Gdansk

More Information
  • Responsible Party: Medical University of Gdansk
  • ClinicalTrials.gov Identifier: NCT03944681 History of Changes
  • Other Study ID Numbers: KB01
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: September 10, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Medical University of Gdansk: postoperative nausea and vomiting
    corrected QT interval
    transmural dispersion of repolarisation
    torsadogenic action
  • Additional relevant MeSH terms: Postoperative Nausea and Vomiting