Pre-medication With Alfentanil vs Placebo During ECT

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-04

Study Completion Date

2020-02-17

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.

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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.

Conditions

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Blood Pressure Electroconvulsive Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

study med prepared by a provider not involved in the anesthesia care of the subject

Study Groups

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Alfentanil

Group Type ACTIVE_COMPARATOR

Alfentanil

Intervention Type DRUG

Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed

placebo

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed

Interventions

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Alfentanil

Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed

Intervention Type DRUG

Placebos

Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No