Effects of Pre-medication With Alfentanil on Hemodynamics During and Immediately Following Electroconvulsive Therapy (ECT)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Systolic Blood Pressure Change
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
study med prepared by a provider not involved in the anesthesia care of the subject
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Alfentanil
Intervention: Alfentanil (Drug)
placebo
Intervention: Placebos (Drug)
Outcomes
Primary Outcomes
Systolic Blood Pressure Change
Time Frame: Baseline and up to 90 minutes
comparison of Systolic blood pressure changes alfentanil vs placebo
Secondary Outcomes
- Total Time Subject Spent In-Room(up to 90 minutes)
- Diastolic Blood Pressure Change(Baseline and up to 90 minutes)
- Heart Rate(90 minutes)
- Maximum Heart Rate(Baseline and up to 90 minutes)
- Minimum Heart Rate(Baseline and up to 90 minutes)
- Doses of Antihypertensive Medication(90 minutes)
- Time to Return of Spontaneous Ventilation(up to 90 minutes)
- Severity of Headache in the Post Anesthesia Care Unit(up to 90 minutes)
- Satisfaction With the Anesthetic Post-procedure(up to 90 minutes)