Pre-medication With Alfentanil vs Placebo During ECT

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359395
• Other study ID #: IRB00045800
• Status: Completed
• Phase: Phase 4
• Start date: June 4, 2018
• Est. completion date: February 17, 2020

Study information

• Verified date: February 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 17, 2020
• Est. primary completion date: February 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Electroconvulsive Therapy

Intervention

Drug:
• Alfentanil
Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
• Placebos
Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed

Locations

Country	Name	City	State
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure Change	comparison of Systolic blood pressure changes alfentanil vs placebo	Baseline and up to 90 minutes
Secondary	Diastolic Blood Pressure Change	comparison of diastolic blood pressure change alfentanil vs placebo	Baseline and up to 90 minutes
Secondary	Heart Rate	comparison of heart rate change alfentanil vs placebo	Baseline and up to 15 seconds
Secondary	Heart Rate	comparison of heart rate change alfentanil vs placebo	Baseline and up to 30 seconds
Secondary	Heart Rate	comparison of heart rate change alfentanil vs placebo	90 minutes
Secondary	Maximum Heart Rate	comparison of heart rate change alfentanil vs placebo	Baseline and up to 90 minutes
Secondary	Minimum Heart Rate	comparison of heart rate change alfentanil vs placebo	Baseline and up to 90 minutes
Secondary	Doses of Antihypertensive Medication	comparison of amounts of medications needed to treat blood pressure between the 2 groups	90 minutes
Secondary	Time to Return of Spontaneous Ventilation	time to return to breathing without assistance	up to 90 minutes
Secondary	Total Time Subject Spent In-Room	comparison of amounts time spent in-room between the 2 groups	up to 90 minutes
Secondary	Severity of Headache in the Post Anesthesia Care Unit	comparison between alfentanil vs placebo - Subject questionnaire with scale: 0 -10 - with 10 being the worst	up to 90 minutes
Secondary	Satisfaction With the Anesthetic Post-procedure	comparison between alfentanil vs placebo - Subject questionnaire with scale: 0-10 - with 10 being the worst	up to 90 minutes