Phase 4
Completed N=99
Pre-medication With Alfentanil vs Placebo During ECT
Blood Pressure · Electroconvulsive Therapy
Source: ClinicalTrials.gov NCT03359395 ↗
Enrolled (actual)
99
Serious AEs
1.2%
Results posted
Jul 2021
Primary outcomePrimary: Systolic Blood Pressure Change — 22.011; 38.908 mmHg
◆ Published Evidence
Emerging
3citations · ~1 / year
Alfentanil Pretreatment for Electroconvulsive Therapy-Associated Hemodynamic Lability: A Prospective Randomized Crossover 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.
Linked Publications
-
Alfentanil Pretreatment for Electroconvulsive Therapy-Associated Hemodynamic Lability: A Prospective Randomized Crossover Trial.
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 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 | — |
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
Data sourced from ClinicalTrials.gov (NCT03359395) and the linked publication. 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. Informational only — not medical advice.