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Gender Influence on Torsadogenic Actions of Droperidol.

Sponsor
Medical University of Gdansk (Other)
Overall Status
Recruiting
CT.gov ID
NCT03944681
Collaborator
(none)
70
Enrollment
1
Location
1
Arm
19.3
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
  • Drug: Droperidol Injectable Solution
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
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 :
Apr 23, 2019
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 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.
Other Names:
  • electrocardiogram analysis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. QT and corrected QT interval time [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    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

    Locations

    Site City State Country Postal Code
    1 Medical University of Gdansk Gdansk Poland 80211

    Sponsors and Collaborators

    • Medical University of Gdansk

    Investigators

    • Principal Investigator: Radoslaw Owczuk, Professor, Medical University of Gdansk

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radoslaw Owczuk, Clinical Professor, Head of Department of Anaesthesiology and Intensive Care, Medical University of Gdansk
    ClinicalTrials.gov Identifier:
    NCT03944681
    Other Study ID Numbers:
    • KB01
    First Posted:
    May 9, 2019
    Last Update Posted:
    Sep 10, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    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 Radoslaw Owczuk, Clinical Professor, Head of Department of Anaesthesiology and Intensive Care, Medical University of Gdansk
    postoperative nausea and vomiting
    torsadogenic action
    transmural dispersion of repolarisation
    corrected QT interval
    Additional relevant MeSH terms:
    Postoperative Nausea and Vomiting
    Droperidol

    Study Results

    No Results Posted as of Sep 10, 2020