CHRISTUS Spohn Hospital Corpus Christi-Shoreline
Corpus Christi, Texas, 78405, United States
Location status: Recruiting
Location contact
Aaron Bartoe, DO, MS
CONTACT
Peter Richman, MD, MS
CONTACT
NCT Number: NCT06726811
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Corpus Christi, Texas, 78405, United States
Location status: Recruiting
Aaron Bartoe, DO, MS
CONTACT
Peter Richman, MD, MS
CONTACT
The investigators plan to conduct ECG evaluation for QT interval both before and after patients are given 2.5 mg of droperidol. Specifically, a convenience sample of consenting adult patients, ages 18 years and older, who present to the ED, and are in a cardiac-monitored bed in the ED who, at the discretion of their treating physician, have an ECG recorded and then receive a dose of 2.5 mg of droperidol IV will be enrolled in our study. The investigators will then have a second ECG printed at least 5 minutes and no more than 30 minutes after the droperidol is given. Change in QT interval between the two ECGs will be documented. It may be necessary to review the EMR in order to document the time of droperidol administration.
These post-droperidol ECGs will not be stored in the electronic medical record nor read by a physician in real time. Treatment decisions regarding the patient's medical care in the ED will not be affected by these second ECGs; decisions about whether other ECGs may be needed will be made by the treating physician. The primary study outcome will be the percentage of the study population who experience a clinically significant increase in QTc after low-dose droperidol administration, defined as an increase in QTc of 20 ms or greater. Secondary outcome measures will be the mean change in QTc across the study population, and the percentage of the study population for whom the administration of low-dose droperidol is associated with an increase in QTc that re-classifies them as having a prolonged QTc (>450 ms in men and >470 ms in women).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2.5 mg
Time frame: 30 minutes after Droperidol is given.
We plan to conduct ECG evaluation for QT interval both before and after patients are given 2.5 mg of droperidol.
Contact information is provided by the study sponsor or research team.
Aaron K Bartoe, DO, MS
CONTACT
Peter Richman, MD, MBA
CONTACT
CHRISTUS Health
Other
Low-Dose Droperidol and Its Association with QTc Interval Changes in Emergency Department Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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