Clinical trial NCT03359395: Pre-medication With Alfentanil vs Placebo During ECT
Official title: Effects of Pre-medication With Alfentanil on Hemodynamics During and Immediately Following Electroconvulsive Therapy (ECT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Pressure
Electroconvulsive Therapy
Keywords: Anesthesia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic Blood Pressure Change
timeFrame: Baseline and up to 90 minutes
Secondary outcomes:
measure: Diastolic Blood Pressure Change
timeFrame: Baseline and up to 90 minutes
measure: Heart Rate
timeFrame: Baseline and up to 15 seconds
measure: Heart Rate
timeFrame: Baseline and up to 30 seconds
measure: Heart Rate
timeFrame: 90 minutes
measure: Maximum Heart Rate
timeFrame: Baseline and up to 90 minutes
measure: Minimum Heart Rate
timeFrame: Baseline and up to 90 minutes
measure: Doses of Antihypertensive Medication
timeFrame: 90 minutes
measure: Time to Return of Spontaneous Ventilation
timeFrame: up to 90 minutes
measure: Total Time Subject Spent In-Room
timeFrame: up to 90 minutes
measure: Severity of Headache in the Post Anesthesia Care Unit
timeFrame: up to 90 minutes
measure: Satisfaction With the Anesthetic Post-procedure
timeFrame: up to 90 minutes
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest School of Medicne
name: Quinn McCutchen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCutchen TM, Gligorovic PV, Tighe NTG, Templeton TW, Saha AK. Alfentanil Pretreatment for Electroconvulsive Therapy-Associated Hemodynamic Lability: A Prospective Randomized Crossover Trial. J ECT. 2023 Jun 1;39(2):84-90. doi: 10.1097/YCT.0000000000000885. Epub 2022 Oct 1.