Pre-medication With Alfentanil vs Placebo During ECT

NCT03359395 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00045800
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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

Keywords

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure Change

  comparison of Systolic blood pressure changes alfentanil vs placebo

  Baseline and up to 90 minutes

Secondary Outcomes (11)

• Diastolic Blood Pressure Change

  Baseline and up to 90 minutes

• Heart Rate

  Baseline and up to 15 seconds

• Heart Rate

  Baseline and up to 30 seconds

• Heart Rate

  90 minutes

• Maximum Heart Rate

  Baseline and up to 90 minutes

Study Arms (2)

Alfentanil

ACTIVE COMPARATOR

Drug: Alfentanil

placebo

PLACEBO COMPARATOR

Drug: Placebos

Interventions

Alfentanil DRUG

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

Alfentanil

Placebos DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> /=18 years
• Males or females
• Anticipating electroconvulsive therapy to treat refractory depressive disorder

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• McCutchen TM, Gligorovic PV, Tighe NTG, Templeton TW, Saha AK. Alfentanil Pretreatment for Electroconvulsive Therapy-Associated Hemodynamic Lability: A Prospective Randomized Crossover Trial. J ECT. 2023 Jun 1;39(2):84-90. doi: 10.1097/YCT.0000000000000885. Epub 2022 Oct 1.

  PMID: 36215414 DERIVED

MeSH Terms

Interventions

Alfentanil

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: T. Quinn McCutchen, MD
• Organization: Wake Forest Health Science

tmccutch@wakehealth.edu

336.716.4498

Study Officials

• Quinn McCutchen, MD

  Wake Forest School of Medicne

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: study med prepared by a provider not involved in the anesthesia care of the subject
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: June 4, 2018
• Primary Completion: February 17, 2020
• Study Completion: February 17, 2020
• Last Updated: July 8, 2021
• Results First Posted: July 8, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)