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Pre-medication With Alfentanil vs Placebo During ECT

NCT03359395 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-07-08

Study results available
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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.

Conditions

  • Blood Pressure
  • Electroconvulsive Therapy

Interventions

DRUG

Alfentanil

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

DRUG

Placebos

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

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Quinn McCutchen, MD · Wake Forest School of Medicne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-04
Primary Completion
2020-02-17
Completion
2020-02-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03359395 on ClinicalTrials.gov