Pre-medication With Alfentanil vs Placebo During ECT

Phase 4

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Under the age of 18
Allergy to alfentanil
Allergy to other standard anesthetic medications utilized in the course of ECT (glycopyrrolate, methohexital, and succinylcholine)
History of malignant hyperthermia
History of severe airway obstruction, bronchospasm or laryngospasm
History of recent myocardial infarction, ventricular arrhythmia
Adverse reaction to ECT requiring premedication with lidocaine or atropine
Non-English speaking
Patients unable to consent for themselves
Current pregnancy

Arm && Interventions

Group	Intervention	Description
placebo	Placebos	-
Alfentanil	Alfentanil	-

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure Change	Baseline and up to 90 minutes	comparison of Systolic blood pressure changes alfentanil vs placebo

Secondary Outcome Measures

Name	Time	Method
Total Time Subject Spent In-Room	up to 90 minutes	comparison of amounts time spent in-room between the 2 groups
Diastolic Blood Pressure Change	Baseline and up to 90 minutes	comparison of diastolic blood pressure change alfentanil vs placebo
Heart Rate	90 minutes	comparison of heart rate change alfentanil vs placebo
Maximum Heart Rate	Baseline and up to 90 minutes	comparison of heart rate change alfentanil vs placebo
Minimum Heart Rate	Baseline and up to 90 minutes	comparison of heart rate change alfentanil vs placebo
Doses of Antihypertensive Medication	90 minutes	comparison of amounts of medications needed to treat blood pressure between the 2 groups
Time to Return of Spontaneous Ventilation	up to 90 minutes	time to return to breathing without assistance
Severity of Headache in the Post Anesthesia Care Unit	up to 90 minutes	comparison between alfentanil vs placebo - Subject questionnaire with scale: 0 -10 - with 10 being the worst
Satisfaction With the Anesthetic Post-procedure	up to 90 minutes	comparison between alfentanil vs placebo - Subject questionnaire with scale: 0-10 - with 10 being the worst