NCT03359395

Pre-medication With Alfentanil vs Placebo During ECT

Effects of Pre-medication With Alfentanil on Hemodynamics During and Immediately Following Electroconvulsive Therapy (ECT)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blood Pressure
• Electroconvulsive Therapy

Interventions

Type	Name	Description
DRUG	Alfentanil	Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
DRUG	Placebos	Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed

Timeline

• Start date: 2018-06-04
• Primary completion: 2020-02-17
• Completion: 2020-02-17
• First posted: 2017-12-02
• Last updated: 2021-07-08
• Results posted: 2021-07-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study