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OpenTrials
Completed

NCT Number: NCT03359395

Pre-medication With Alfentanil vs Placebo During 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alfentanil

Drug

Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed

Placebos

Drug

Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed

Primary outcomes

  1. Systolic Blood Pressure Change

    Time frame: Baseline and up to 90 minutes

    comparison of Systolic blood pressure changes alfentanil vs placebo

Secondary outcomes

  1. Diastolic Blood Pressure Change

    Time frame: Baseline and up to 90 minutes

    comparison of diastolic blood pressure change alfentanil vs placebo

  2. Heart Rate

    Time frame: Baseline and up to 15 seconds

    comparison of heart rate change alfentanil vs placebo

  3. Heart Rate

    Time frame: Baseline and up to 30 seconds

    comparison of heart rate change alfentanil vs placebo

  4. Heart Rate

    Time frame: 90 minutes

    comparison of heart rate change alfentanil vs placebo

  5. Maximum Heart Rate

    Time frame: Baseline and up to 90 minutes

    comparison of heart rate change alfentanil vs placebo

  6. Minimum Heart Rate

    Time frame: Baseline and up to 90 minutes

    comparison of heart rate change alfentanil vs placebo

  7. Doses of Antihypertensive Medication

    Time frame: 90 minutes

    comparison of amounts of medications needed to treat blood pressure between the 2 groups

  8. Time to Return of Spontaneous Ventilation

    Time frame: up to 90 minutes

    time to return to breathing without assistance

  9. Total Time Subject Spent In-Room

    Time frame: up to 90 minutes

    comparison of amounts time spent in-room between the 2 groups

  10. Severity of Headache in the Post Anesthesia Care Unit

    Time frame: up to 90 minutes

    comparison between alfentanil vs placebo - Subject questionnaire with scale: 0 -10 - with 10 being the worst

  11. Satisfaction With the Anesthetic Post-procedure

    Time frame: up to 90 minutes

    comparison between alfentanil vs placebo - Subject questionnaire with scale: 0-10 - with 10 being the worst

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 2, 2017
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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