Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
NCT Number: NCT03359395
Hemodynamic changes associated with the conduct of electroconvulsive therapy may be minimized with the administration of alfentanil as part of their anesthetic regimen. This study proposes to compare the effects in a blinded fashion. Currently alfentanil is an FDA approved drug used on a daily basis by anesthesiologists on other surgeries so this is not a new indication.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Winston-Salem, North Carolina, 27157, United States
Electroconvulsive therapy is associated with brief hemodynamic alterations that in some patients may be well outside the range of normalcy and potentially dangerous to the patient (Duma A, et al). This cardiovascular response is caused by activation of the autonomic nervous system and consists of an initial parasympathetic response rapidly followed by sympathetically mediated tachycardia and hypertension. The ultra-short acting synthetic opioid alfentanil has a rapid onset and duration of action that mirrors the duration of hemodynamic perturbation associated with Electroconvulsive Therapy (ECT) while having minimal or no effect on the duration or quality of the seizure. This drug may be effective in blunting the hemodynamic perturbations associated with ECT with a minimal amount of side effects.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Time frame: Baseline and up to 90 minutes
comparison of Systolic blood pressure changes alfentanil vs placebo
Time frame: Baseline and up to 90 minutes
comparison of diastolic blood pressure change alfentanil vs placebo
Time frame: Baseline and up to 15 seconds
comparison of heart rate change alfentanil vs placebo
Time frame: Baseline and up to 30 seconds
comparison of heart rate change alfentanil vs placebo
Time frame: 90 minutes
comparison of heart rate change alfentanil vs placebo
Time frame: Baseline and up to 90 minutes
comparison of heart rate change alfentanil vs placebo
Time frame: Baseline and up to 90 minutes
comparison of heart rate change alfentanil vs placebo
Time frame: 90 minutes
comparison of amounts of medications needed to treat blood pressure between the 2 groups
Time frame: up to 90 minutes
time to return to breathing without assistance
Time frame: up to 90 minutes
comparison of amounts time spent in-room between the 2 groups
Time frame: up to 90 minutes
comparison between alfentanil vs placebo - Subject questionnaire with scale: 0 -10 - with 10 being the worst
Time frame: up to 90 minutes
comparison between alfentanil vs placebo - Subject questionnaire with scale: 0-10 - with 10 being the worst
Wake Forest University Health Sciences
Other
Effects of Pre-medication With Alfentanil on Hemodynamics During and Immediately Following Electroconvulsive Therapy (ECT)
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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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