Pre-medication With Alfentanil vs Placebo During ECT

Completed · Phase 4 · Has a placebo group

Conditions studied: Blood Pressure, Electroconvulsive Therapy

In brief

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.

Key facts

Study ID

NCT03359395

Run by

Wake Forest University Health Sciences

People needed

100

Starts

2018-06-04

Expected to finish

2020-02-17

Last updated by the study team

2021-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > /=18 years
• Males or females
• Anticipating electroconvulsive therapy to treat refractory depressive disorder

You may not qualify if…

• 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

Where it is running

• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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