Status:
COMPLETED
Pre-medication With Alfentanil vs Placebo During ECT
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Blood Pressure
Electroconvulsive Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
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). Thi...
Eligibility Criteria
Inclusion
- Age \> /=18 years
- Males or females
- Anticipating electroconvulsive therapy to treat refractory depressive disorder
Exclusion
- 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
Key Trial Info
Start Date :
June 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03359395
Start Date
June 4 2018
End Date
February 17 2020
Last Update
July 8 2021
Active Locations (1)
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1
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157