Droperidol and QTc Interval Changes in ED Patients

NCT06726811 | Recruiting FDA Drug

• 1 other identifier: 2025-026
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives To assess the association of low-dose Droperidol administration in the emergency department with changes in the QTc interval. Hypothesis Our study is designed to test the null hypothesis that there will be no clinically significant change in QTc interval after administration of 2.5mg of IV Droperidol during an emergency department visit.

Conditions

Emergency Department Patient; QTc Intervals Changes

Keywords

Droperidol; QTc Interval Changes; Emergency Department Patients

Outcome Measures

Primary Outcomes (1)

• ECG Evaluation

  We plan to conduct ECG evaluation for QT interval both before and after patients are given 2.5 mg of droperidol.

  30 minutes after Droperidol is given.

Interventions

Droperidol injection DRUG

2.5 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* The population being studied will be a convenience sample of adult emergency department patients. * Eligibility in the study will be based on the treating physician's decision to have administered droperidol and to obtain an ECG - participation in the study will not affect the patient's care. * The minimum number of study subjects will be 100. * The maximum number of study subjects will be 500. * There will be no use of special subject populations. * Investigators will also track how many eligible patients refuse to participate. (See "Participation Status" on the survey instrument, Data Collection Form) * Written consent will be required for each participant at the top of the survey. (See "Survey Instrument", Data Collection Form) * Patients will be enrolled only once. * Participants will not receive any form of compensation and will not be billed for the additional ECG. * Vulnerable adult populations may be included who are able to give consent to participate.

You may not qualify if:

• Refusal to provide consent.
• Administration of droperidol before the first ECG is performed.
• Inability to complete the consent form and questionnaire due to clinical instability, severe pain, or disorientation as determined by a study physician.

Sponsors & Collaborators

• CHRISTUS Health: lead

Study Sites (1)

CHRISTUS Spohn Hospital Corpus Christi-Shoreline

Corpus Christi, Texas, 78405, United States

RECRUITING

Related Publications (15)

• White PF. Droperidol: a cost-effective antiemetic for over thirty years. Anesth Analg. 2002 Oct;95(4):789-90. doi: 10.1097/00000539-200210000-00001. No abstract available.

  PMID: 12351246 BACKGROUND

• Trinkley KE, Page RL 2nd, Lien H, Yamanouye K, Tisdale JE. QT interval prolongation and the risk of torsades de pointes: essentials for clinicians. Curr Med Res Opin. 2013 Dec;29(12):1719-26. doi: 10.1185/03007995.2013.840568. Epub 2013 Sep 23.

  PMID: 24020938 BACKGROUND

• Pickham D, Helfenbein E, Shinn JA, Chan G, Funk M, Weinacker A, Liu JN, Drew BJ. High prevalence of corrected QT interval prolongation in acutely ill patients is associated with mortality: results of the QT in Practice (QTIP) Study. Crit Care Med. 2012 Feb;40(2):394-9. doi: 10.1097/CCM.0b013e318232db4a.

  PMID: 22001585 BACKGROUND

• Nachimuthu S, Assar MD, Schussler JM. Drug-induced QT interval prolongation: mechanisms and clinical management. Ther Adv Drug Saf. 2012 Oct;3(5):241-53. doi: 10.1177/2042098612454283.

  PMID: 25083239 BACKGROUND

• Jackson CW, Sheehan AH, Reddan JG. Evidence-based review of the black-box warning for droperidol. Am J Health Syst Pharm. 2007 Jun 1;64(11):1174-86. doi: 10.2146/ajhp060505.

  PMID: 17519460 BACKGROUND

• Haddad PM, Anderson IM. Antipsychotic-related QTc prolongation, torsade de pointes and sudden death. Drugs. 2002;62(11):1649-71. doi: 10.2165/00003495-200262110-00006.

  PMID: 12109926 BACKGROUND

• Domino KB, Anderson EA, Polissar NL, Posner KL. Comparative efficacy and safety of ondansetron, droperidol, and metoclopramide for preventing postoperative nausea and vomiting: a meta-analysis. Anesth Analg. 1999 Jun;88(6):1370-9. doi: 10.1097/00000539-199906000-00032.

  PMID: 10357347 BACKGROUND

• Charbit B, Albaladejo P, Funck-Brentano C, Legrand M, Samain E, Marty J. Prolongation of QTc interval after postoperative nausea and vomiting treatment by droperidol or ondansetron. Anesthesiology. 2005 Jun;102(6):1094-100. doi: 10.1097/00000542-200506000-00006.

  PMID: 15915019 BACKGROUND

• Charbit B, Alvarez JC, Dasque E, Abe E, Demolis JL, Funck-Brentano C. Droperidol and ondansetron-induced QT interval prolongation: a clinical drug interaction study. Anesthesiology. 2008 Aug;109(2):206-12. doi: 10.1097/ALN.0b013e31817fd8c8.

  PMID: 18648229 BACKGROUND

• Abriel H, Schlapfer J, Keller DI, Gavillet B, Buclin T, Biollaz J, Stoller R, Kappenberger L. Molecular and clinical determinants of drug-induced long QT syndrome: an iatrogenic channelopathy. Swiss Med Wkly. 2004 Nov 27;134(47-48):685-94. doi: 10.4414/smw.2004.10532.

  PMID: 15616901 BACKGROUND

• Cole JB, Lee SC, Martel ML, Smith SW, Biros MH, Miner JR. The Incidence of QT Prolongation and Torsades des Pointes in Patients Receiving Droperidol in an Urban Emergency Department. West J Emerg Med. 2020 Jul 2;21(4):728-736. doi: 10.5811/westjem.2020.4.47036.

  PMID: 32726229 BACKGROUND

• Fortney JT, Gan TJ, Graczyk S, Wetchler B, Melson T, Khalil S, McKenzie R, Parrillo S, Glass PS, Moote C, Wermeling D, Parasuraman TV, Duncan B, Creed MR. A comparison of the efficacy, safety, and patient satisfaction of ondansetron versus droperidol as antiemetics for elective outpatient surgical procedures. S3A-409 and S3A-410 Study Groups. Anesth Analg. 1998 Apr;86(4):731-8. doi: 10.1097/00000539-199804000-00011.

  PMID: 9539593 BACKGROUND

• Hernandez-Rodriguez L, Bellolio F, Cabrera D, Mattson AE, VanMeter D, Grush AE, Oliveira J E Silva L. Prospective real-time evaluation of the QTc interval variation after low-dose droperidol among emergency department patients. Am J Emerg Med. 2022 Feb;52:212-219. doi: 10.1016/j.ajem.2021.12.039. Epub 2021 Dec 22.

  PMID: 34959024 BACKGROUND

• Tracz K, Owczuk R. Small doses of droperidol do not present relevant torsadogenic actions: a double-blind, ondansetron-controlled study. Br J Clin Pharmacol. 2015 Apr;79(4):669-76. doi: 10.1111/bcp.12527.

  PMID: 25293524 BACKGROUND

• Weibel S, Rucker G, Eberhart LH, Pace NL, Hartl HM, Jordan OL, Mayer D, Riemer M, Schaefer MS, Raj D, Backhaus I, Helf A, Schlesinger T, Kienbaum P, Kranke P. Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis. Cochrane Database Syst Rev. 2020 Oct 19;10(10):CD012859. doi: 10.1002/14651858.CD012859.pub2.

  PMID: 33075160 BACKGROUND

MeSH Terms

Interventions

Droperidol

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Aaron K Bartoe, DO, MS

CONTACT

(863) 532-8408; aaronkbartoe@gmail.com

Peter Richman, MD, MBA

CONTACT

prichmanmdmba@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 10, 2024
• Study Start: October 17, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)