Pre-medication With Alfentanil vs Placebo During ECT

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Electroconvulsive Therapy; Blood Pressure

Treatments: Drug: Placebos; Drug: Alfentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT03359395

IRB00045800

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Alfentanil

Active Comparator group

Treatment:

Drug: Alfentanil

placebo

Placebo Comparator group

Treatment:

Drug: Placebos