Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-05-31 @ 8:25 PM
Study NCT ID:
NCT03359395
Status:
COMPLETED
Last Update Posted:
2021-07-08
First Post:
2017-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pre-medication With Alfentanil vs Placebo During ECT
Sponsor:
Organization:
Raw JSON
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'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-27', 'size': 146993, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-26T08:39', 'hasProtocol': True}, {'date': '2019-07-02', 'size': 157892, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-05-08T10:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'study med prepared by a provider not involved in the anesthesia care of the subject'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-07', 'studyFirstSubmitDate': '2017-11-27', 'resultsFirstSubmitDate': '2021-04-28', 'studyFirstSubmitQcDate': '2017-11-27', 'lastUpdatePostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-07', 'studyFirstPostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic Blood Pressure Change', 'timeFrame': 'Baseline and up to 90 minutes', 'description': 'comparison of Systolic blood pressure changes alfentanil vs placebo'}], 'secondaryOutcomes': [{'measure': 'Diastolic Blood Pressure Change', 'timeFrame': 'Baseline and up to 90 minutes', 'description': 'comparison of diastolic blood pressure change alfentanil vs placebo'}, {'measure': 'Heart Rate', 'timeFrame': 'Baseline and up to 15 seconds', 'description': 'comparison of heart rate change alfentanil vs placebo'}, {'measure': 'Heart Rate', 'timeFrame': 'Baseline and up to 30 seconds', 'description': 'comparison of heart rate change alfentanil vs placebo'}, {'measure': 'Heart Rate', 'timeFrame': '90 minutes', 'description': 'comparison of heart rate change alfentanil vs placebo'}, {'measure': 'Maximum Heart Rate', 'timeFrame': 'Baseline and up to 90 minutes', 'description': 'comparison of heart rate change alfentanil vs placebo'}, {'measure': 'Minimum Heart Rate', 'timeFrame': 'Baseline and up to 90 minutes', 'description': 'comparison of heart rate change alfentanil vs placebo'}, {'measure': 'Doses of Antihypertensive Medication', 'timeFrame': '90 minutes', 'description': 'comparison of amounts of medications needed to treat blood pressure between the 2 groups'}, {'measure': 'Time to Return of Spontaneous Ventilation', 'timeFrame': 'up to 90 minutes', 'description': 'time to return to breathing without assistance'}, {'measure': 'Total Time Subject Spent In-Room', 'timeFrame': 'up to 90 minutes', 'description': 'comparison of amounts time spent in-room between the 2 groups'}, {'measure': 'Severity of Headache in the Post Anesthesia Care Unit', 'timeFrame': 'up to 90 minutes', 'description': 'comparison between alfentanil vs placebo - Subject questionnaire with scale: 0 -10 - with 10 being the worst'}, {'measure': 'Satisfaction With the Anesthetic Post-procedure', 'timeFrame': 'up to 90 minutes', 'description': 'comparison between alfentanil vs placebo - Subject questionnaire with scale: 0-10 - with 10 being the worst'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anesthesia'], 'conditions': ['Blood Pressure', 'Electroconvulsive Therapy']}, 'referencesModule': {'references': [{'pmid': '36215414', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> /=18 years\n* Males or females\n* Anticipating electroconvulsive therapy to treat refractory depressive disorder\n\nExclusion Criteria:\n\n* Under the age of 18\n* Allergy to alfentanil\n* Allergy to other standard anesthetic medications utilized in the course of ECT (glycopyrrolate, methohexital, and succinylcholine)\n* History of malignant hyperthermia\n* History of severe airway obstruction, bronchospasm or laryngospasm\n* History of recent myocardial infarction, ventricular arrhythmia\n* Adverse reaction to ECT requiring premedication with lidocaine or atropine\n* Non-English speaking\n* Patients unable to consent for themselves\n* Current pregnancy'}, 'identificationModule': {'nctId': 'NCT03359395', 'briefTitle': 'Pre-medication With Alfentanil vs Placebo During ECT', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Effects of Pre-medication With Alfentanil on Hemodynamics During and Immediately Following Electroconvulsive Therapy (ECT)', 'orgStudyIdInfo': {'id': 'IRB00045800'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Alfentanil', 'interventionNames': ['Drug: Alfentanil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Alfentanil', 'type': 'DRUG', 'description': 'Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed', 'armGroupLabels': ['Alfentanil']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Quinn McCutchen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest School of Medicne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}