Pre-medication With Alfentanil vs Placebo During ECT

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Electroconvulsive Therapy
• Intervention / Treatment: Drug: Alfentanil; Drug: Placebos

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebos; Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Active Comparator: Alfentanil	Drug: Alfentanil; Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure Change	comparison of Systolic blood pressure changes alfentanil vs placebo	Baseline and up to 90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic Blood Pressure Change	comparison of diastolic blood pressure change alfentanil vs placebo	Baseline and up to 90 minutes
Heart Rate	comparison of heart rate change alfentanil vs placebo	Baseline and up to 15 seconds
Heart Rate	comparison of heart rate change alfentanil vs placebo	Baseline and up to 30 seconds
Heart Rate	comparison of heart rate change alfentanil vs placebo	90 minutes
Maximum Heart Rate	comparison of heart rate change alfentanil vs placebo	Baseline and up to 90 minutes
Minimum Heart Rate	comparison of heart rate change alfentanil vs placebo	Baseline and up to 90 minutes
Doses of Antihypertensive Medication	comparison of amounts of medications needed to treat blood pressure between the 2 groups	90 minutes
Time to Return of Spontaneous Ventilation	time to return to breathing without assistance	up to 90 minutes
Total Time Subject Spent In-Room	comparison of amounts time spent in-room between the 2 groups	up to 90 minutes
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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Quinn McCutchen, MD, Wake Forest School of Medicne

Publications and helpful links

General Publications

• 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. 2022 Oct 1. doi: 10.1097/YCT.0000000000000885. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2018
• Primary Completion (Actual): February 17, 2020
• Study Completion (Actual): February 17, 2020

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Alfentanil
• Other Study ID Numbers: IRB00045800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No