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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
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
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Systolic Blood Pressure Change
comparison of Systolic blood pressure changes alfentanil vs placebo
Time frame: Baseline and up to 90 minutes
Diastolic Blood Pressure Change
comparison of diastolic blood pressure change alfentanil vs placebo
Time frame: Baseline and up to 90 minutes
Heart Rate
comparison of heart rate change alfentanil vs placebo
Time frame: Baseline and up to 15 seconds
Heart Rate
comparison of heart rate change alfentanil vs placebo
Time frame: Baseline and up to 30 seconds
Heart Rate
comparison of heart rate change alfentanil vs placebo
Time frame: 90 minutes
Maximum Heart Rate
comparison of heart rate change alfentanil vs placebo
Time frame: Baseline and up to 90 minutes
Minimum Heart Rate
comparison of heart rate change alfentanil vs placebo
Time frame: Baseline and up to 90 minutes
Doses of Antihypertensive Medication
comparison of amounts of medications needed to treat blood pressure between the 2 groups
Time frame: 90 minutes
Time to Return of Spontaneous Ventilation
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time to return to breathing without assistance
Time frame: up to 90 minutes
Total Time Subject Spent In-Room
comparison of amounts time spent in-room between the 2 groups
Time frame: up to 90 minutes
Severity of Headache in the Post Anesthesia Care Unit
comparison between alfentanil vs placebo - Subject questionnaire with scale: 0 -10 - with 10 being the worst
Time frame: up to 90 minutes
Satisfaction With the Anesthetic Post-procedure
comparison between alfentanil vs placebo - Subject questionnaire with scale: 0-10 - with 10 being the worst
Time frame: up to 90 minutes