Pre-medication With Alfentanil vs Placebo During ECT

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Pre-medication With Alfentanil on Hemodynamics During and Immediately Following Electroconvulsive Therapy (ECT)

Conditions
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Blood Pressure, Electroconvulsive Therapy

Intervention / Treatment
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* Drug: Alfentanil
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > /=18 years Males or females Anticipating electroconvulsive therapy to treat refractory depressive disorder 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alfentanil<br> | Drug: Alfentanil<br>* Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed<br>|
| Placebo Comparator: placebo<br> | Drug: Placebos<br>* Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure Change | comparison of Systolic blood pressure changes alfentanil vs placebo | Baseline and up to 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic Blood Pressure Change | comparison of diastolic blood pressure change alfentanil vs placebo | Baseline and up to 90 minutes | 
| Heart Rate | comparison of heart rate change alfentanil vs placebo | Baseline and up to 15 seconds | 
| Heart Rate | comparison of heart rate change alfentanil vs placebo | Baseline and up to 30 seconds | 
| Heart Rate | comparison of heart rate change alfentanil vs placebo | 90 minutes | 
| Maximum Heart Rate | comparison of heart rate change alfentanil vs placebo | Baseline and up to 90 minutes | 
| Minimum Heart Rate | comparison of heart rate change alfentanil vs placebo | Baseline and up to 90 minutes | 
| Doses of Antihypertensive Medication | comparison of amounts of medications needed to treat blood pressure between the 2 groups | 90 minutes | 
| Time to Return of Spontaneous Ventilation | time to return to breathing without assistance | up to 90 minutes | 
| Total Time Subject Spent In-Room | comparison of amounts time spent in-room between the 2 groups | 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 | 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 | up to 90 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia