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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.
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). This cardiovascular response is caused by activation of the autonomic nervous system and consists of an initial parasympathetic response rapidly followed by sympathetically mediated tachycardia and hypertension. The ultra-short acting synthetic opioid alfentanil has a rapid onset and duration of action that mirrors the duration of hemodynamic perturbation associated with Electroconvulsive Therapy (ECT) while having minimal or no effect on the duration or quality of the seizure. This drug may be effective in blunting the hemodynamic perturbations associated with ECT with a minimal amount of side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alfentanil | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alfentanil | Drug | Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure Change | comparison of Systolic blood pressure changes alfentanil vs placebo | Baseline and up to 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic Blood Pressure Change | comparison of diastolic blood pressure change alfentanil vs placebo | Baseline and up to 90 minutes |
| Heart Rate | comparison of heart rate change alfentanil vs placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quinn McCutchen, MD | Wake Forest School of Medicne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36215414 | Derived | 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. |
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One Subject Withdrew before randomization
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| ID | Title | Description |
|---|---|---|
| FG000 | Alfentanil Then Placebo | Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed |
| FG001 | Placebo Then Afentanil | Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention A / B |
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| |||||||||||||||||||||
| Second Intervention B/A |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alfentanil Then Placebo Arm 1 | Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed |
| BG001 | Placebo Then Alfentanil Arm 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Systolic Blood Pressure Change | comparison of Systolic blood pressure changes alfentanil vs placebo | Posted | Mean | Standard Deviation | mmHg | Baseline and up to 90 minutes |
|
24 hours
Death by suicide the day after one of their electroconvulsive therapy (ECT) procedures was completed - at which time they received Alfentanil during that ECT
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alfentanil | Alfentanil: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide | Social circumstances | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide | Social circumstances | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| T. Quinn McCutchen, MD | Wake Forest Health Science | 336.716.4498 | tmccutch@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2018 | Mar 26, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 2, 2019 | May 8, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015760 | Alfentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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study med prepared by a provider not involved in the anesthesia care of the subject
| Placebos | Drug | Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed |
|
| Baseline and up to 15 seconds |
| Heart Rate | comparison of heart rate change alfentanil vs placebo | Baseline and up to 30 seconds |
| Heart Rate | comparison of heart rate change alfentanil vs placebo | 90 minutes |
| Maximum Heart Rate | comparison of heart rate change alfentanil vs placebo | Baseline and up to 90 minutes |
| Minimum Heart Rate | comparison of heart rate change alfentanil vs placebo | Baseline and up to 90 minutes |
| Doses of Antihypertensive Medication | comparison of amounts of medications needed to treat blood pressure between the 2 groups | 90 minutes |
| Time to Return of Spontaneous Ventilation | time to return to breathing without assistance | up to 90 minutes |
| Total Time Subject Spent In-Room | comparison of amounts time spent in-room between the 2 groups | up to 90 minutes |
| Severity of Headache in the Post Anesthesia Care Unit | comparison between alfentanil vs placebo - Subject questionnaire with scale: 0 -10 - with 10 being the worst | up to 90 minutes |
| Satisfaction With the Anesthetic Post-procedure | comparison between alfentanil vs placebo - Subject questionnaire with scale: 0-10 - with 10 being the worst | up to 90 minutes |
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|
|
Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height (cm) | Mean | Standard Deviation | Centimeters |
|
| Weight (kg) | Mean | Standard Deviation | kilograms |
|
| Units | Counts |
|---|
| Participants |
|
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| Secondary | Diastolic Blood Pressure Change | comparison of diastolic blood pressure change alfentanil vs placebo | Posted | Mean | Standard Deviation | mmHg | Baseline and up to 90 minutes |
|
|
|
| Secondary | Heart Rate | comparison of heart rate change alfentanil vs placebo | Posted | Mean | Standard Deviation | Beats per Minute | Baseline and up to 15 seconds |
|
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| Secondary | Heart Rate | comparison of heart rate change alfentanil vs placebo | Posted | Mean | Standard Deviation | Beats per Minute | Baseline and up to 30 seconds |
|
|
|
| Secondary | Heart Rate | comparison of heart rate change alfentanil vs placebo | Patients had already been discharged from the Post Anesthesia Care Unit (PACU) at 90 minutes time interval and data were not collected | Posted | 90 minutes |
|
|
| Secondary | Maximum Heart Rate | comparison of heart rate change alfentanil vs placebo | Posted | Mean | Standard Deviation | Beats per Minute | Baseline and up to 90 minutes |
|
|
|
| Secondary | Minimum Heart Rate | comparison of heart rate change alfentanil vs placebo | Posted | Mean | Standard Deviation | Beats per Minute | Baseline and up to 90 minutes |
|
|
|
| Secondary | Doses of Antihypertensive Medication | comparison of amounts of medications needed to treat blood pressure between the 2 groups | Patients had already been discharged from the PACU at 90 minutes time interval and data were not collected | Posted | 90 minutes |
|
|
| Secondary | Time to Return of Spontaneous Ventilation | time to return to breathing without assistance | Posted | Mean | Standard Deviation | Minutes | up to 90 minutes |
|
|
|
| Secondary | Total Time Subject Spent In-Room | comparison of amounts time spent in-room between the 2 groups | Posted | Mean | Standard Deviation | Minutes | up to 90 minutes |
|
|
|
| Secondary | Severity of Headache in the Post Anesthesia Care Unit | comparison between alfentanil vs placebo - Subject questionnaire with scale: 0 -10 - with 10 being the worst | Posted | Mean | Standard Deviation | score on a scale | up to 90 minutes |
|
|
|
| Secondary | Satisfaction With the Anesthetic Post-procedure | comparison between alfentanil vs placebo - Subject questionnaire with scale: 0-10 - with 10 being the worst | Posted | Mean | Standard Deviation | score on a scale | up to 90 minutes |
|
|
|
| 1 |
| 87 |
| 1 |
| 87 |
| 0 |
| 87 |
| EG001 | Placebo | Placebos: Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed | 1 | 87 | 1 | 87 | 0 | 87 |
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