Blood PressurePhase 4NCT03359395
Pre-medication With Alfentanil vs Placebo During ECT
A Phase 4 study testing Alfentanil in people with Blood Pressure and Electroconvulsive Therapy, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Electroconvulsive Therapy
- What is being tested?
- Alfentanil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2018to 17 Feb 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > /=18 years
- Males or females
- Anticipating electroconvulsive therapy to treat refractory depressive disorder
Who cannot join
- 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
Show all 10Show fewer
- Adverse reaction to ECT requiring premedication with lidocaine or atropine
- Non-English speaking
- Patients unable to consent for themselves
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Effects of Pre-medication With Alfentanil on Hemodynamics During and Immediately Following Electroconvulsive Therapy (ECT)
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.
Read the detailed description
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.
- Conditions
- Blood Pressure, Electroconvulsive Therapy
- Being tested
- Alfentanil, Placebos
- Keywords
- Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfentanilDrug
Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
PlacebosDrug
Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
| Study group | Role | What they receive |
|---|---|---|
| Alfentanil | Active comparator | Not described Receives: Drug: Alfentanil |
| placebo | Placebo comparator | Not described Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure Change
comparison of Systolic blood pressure changes alfentanil vs placebo
Measured: Baseline and up to 90 minutes
Secondary outcomes (11)
Diastolic Blood Pressure Change
comparison of diastolic blood pressure change alfentanil vs placebo
Measured: Baseline and up to 90 minutes
Heart Rate
comparison of heart rate change alfentanil vs placebo
Measured: Baseline and up to 15 seconds
Heart Rate
comparison of heart rate change alfentanil vs placebo
Measured: Baseline and up to 30 seconds
Heart Rate
comparison of heart rate change alfentanil vs placebo
Measured: 90 minutes
Maximum Heart Rate
comparison of heart rate change alfentanil vs placebo
Measured: Baseline and up to 90 minutes
Minimum Heart Rate
comparison of heart rate change alfentanil vs placebo
Measured: Baseline and up to 90 minutes
Doses of Antihypertensive Medication
comparison of amounts of medications needed to treat blood pressure between the 2 groups
Measured: 90 minutes
Time to Return of Spontaneous Ventilation
time to return to breathing without assistance
Measured: up to 90 minutes
Total Time Subject Spent In-Room
comparison of amounts time spent in-room between the 2 groups
Measured: 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
Measured: 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
Measured: up to 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start4 Jun 2018
- Primary completion17 Feb 2020
- Study completion17 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Quinn McCutchen, MD, Principal investigator, Wake Forest School of Medicne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359395
- Sponsor's protocol ID
- IRB00045800
- Status last verified
- Feb 2020
- First submitted
- 27 Nov 2017
- Last updated
- 8 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36215414
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-medication With Alfentanil on Hemodynamics During and Immediately Following Electroconvulsive Therapy (ECT)
- ClinicalTrials.gov ID
- NCT03359395
- Acronym / sponsor ID
- IRB00045800
- Conditions
- Blood Pressure, Electroconvulsive Therapy
- Keywords
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 2 Dec 2017 (actual)
- Results
- Posted 8 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alfentanil | Active comparator | Drug: Alfentanil |
| placebo | Placebo comparator | Drug: Placebos |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > /=18 years
- Males or females
- Anticipating electroconvulsive therapy to treat refractory depressive disorder
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlfentanilAdministration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed | Drug | Alfentanil |
| PlacebosAdministration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed | Drug | placebo |
Primary outcome
Systolic Blood Pressure Change
Time frame: Baseline and up to 90 minutes
comparison of Systolic blood pressure changes alfentanil vs placebo
11 secondary outcomes
Diastolic Blood Pressure Change
Time frame: Baseline and up to 90 minutes
Heart Rate
Time frame: Baseline and up to 15 seconds
Heart Rate
Time frame: Baseline and up to 30 seconds
Heart Rate
Time frame: 90 minutes
Maximum Heart Rate
Time frame: Baseline and up to 90 minutes
Minimum Heart Rate
Time frame: Baseline and up to 90 minutes
Doses of Antihypertensive Medication
Time frame: 90 minutes
Time to Return of Spontaneous Ventilation
Time frame: up to 90 minutes
Total Time Subject Spent In-Room
Time frame: up to 90 minutes
Severity of Headache in the Post Anesthesia Care Unit
Time frame: up to 90 minutes
Satisfaction With the Anesthetic Post-procedure
Time frame: up to 90 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36215414McCutchen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quinn McCutchen, MD principal investigator
Wake Forest School of Medicne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alfentanil in people with Blood Pressure and Electroconvulsive Therapy, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure Change (time frame: Baseline and up to 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03359395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.