Phase 4 N=99 Randomized Double-blind Treatment

Pre-medication With Alfentanil vs Placebo During ECT

Blood Pressure · Electroconvulsive Therapy

Bottom Line

View on ClinicalTrials.gov: NCT03359395 ↗

Enrolled (actual)

Serious AEs

1.2%

Results posted

Jul 2021

Primary outcome: Primary: Systolic Blood Pressure Change — 22.011; 38.908 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Alfentanil (Drug); Placebos (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Systolic Blood Pressure Change	22.011; 38.908	—
SECONDARY Diastolic Blood Pressure Change	15.26; 23.34	—
SECONDARY Heart Rate	—	—
SECONDARY Heart Rate	—	—
SECONDARY Heart Rate	—	—
SECONDARY Maximum Heart Rate	44.33; 49.66	—
SECONDARY Minimum Heart Rate	12.74; 7.08	—
SECONDARY Doses of Antihypertensive Medication	—	—
SECONDARY Time to Return of Spontaneous Ventilation	8.17; 7.25	—
SECONDARY Total Time Subject Spent In-Room	17.51; 16.43	—
SECONDARY Severity of Headache in the Post Anesthesia Care Unit	2; 2.467	—
SECONDARY Satisfaction With the Anesthetic Post-procedure	8; 8.033	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03359395). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.