Systolic Blood Pressure Change
Primary
· Baseline and up to 90 minutes
comparison of Systolic blood pressure changes alfentanil vs placebo
| Group | Value | 95% CI |
|---|---|---|
| Alfentanil | 22.011 | ± 36.968 |
| Placebo | 38.908 | ± 33.50864 |
Last reviewed · How we verify
NCT03359395
Pre-medication With Alfentanil vs Placebo During ECT
Completed
Phase 4
Results posted
Last updated 8 July 2021
What this trial tests
Phase 4 trial testing Alfentanil in Blood Pressure in 100 participants. Completed in 17 February 2020.
Timeline
4 June 2018
Primary endpoint
17 February 2020
17 February 2020
17 February 2020
Quick facts
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 4 June 2018 |
| Primary completion | 17 February 2020 |
| Estimated completion | 17 February 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Alfentanil (ALFENTANIL) — full drug profile →
- Placebos — full drug profile →
Conditions studied
- Blood Pressure — all drugs for Blood Pressure →
- Electroconvulsive Therapy — all drugs for Electroconvulsive Therapy →
Sponsor
Wake Forest University Health Sciences
Who can join
18 and older, any sex, with Blood Pressure or Electroconvulsive Therapy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Diastolic Blood Pressure Change
Secondary
· Baseline and up to 90 minutes
comparison of diastolic blood pressure change alfentanil vs placebo
| Group | Value | 95% CI |
|---|---|---|
| Alfentanil | 15.26 | ± 23.3848507043 |
| Placebo | 23.34 | ± 24.40 |
Heart Rate
Secondary
· Baseline and up to 15 seconds
comparison of heart rate change alfentanil vs placebo
| Group | Value | 95% CI |
|---|---|---|
| Alfentanil | 26.00 | ± 19.823 |
| Placebo | 28.197674418604 | ± 21.486 |
Heart Rate
Secondary
· Baseline and up to 30 seconds
comparison of heart rate change alfentanil vs placebo
| Group | Value | 95% CI |
|---|---|---|
| Alfentanil | 37.48 | ± 25.46 |
| Placebo | 36.93 | ± 25.46 |
Maximum Heart Rate
Secondary
· Baseline and up to 90 minutes
comparison of heart rate change alfentanil vs placebo
| Group | Value | 95% CI |
|---|---|---|
| Alfentanil | 44.33 | ± 24.274 |
| Placebo | 49.66 | ± 26.629 |
Minimum Heart Rate
Secondary
· Baseline and up to 90 minutes
comparison of heart rate change alfentanil vs placebo
| Group | Value | 95% CI |
|---|---|---|
| Alfentanil | 12.74 | ± 14.674 |
| Placebo | 7.08 | ± 19.221 |
Time to Return of Spontaneous Ventilation
Secondary
· up to 90 minutes
time to return to breathing without assistance
| Group | Value | 95% CI |
|---|---|---|
| Alfentanil | 8.17 | ± 2.483 |
| Placebo | 7.25 | ± 1.869 |
Total Time Subject Spent In-Room
Secondary
· up to 90 minutes
comparison of amounts time spent in-room between the 2 groups
| Group | Value | 95% CI |
|---|---|---|
| Alfentanil | 17.51 | ± 4.640 |
| Placebo | 16.43 | ± 3.940 |
Severity of Headache in the Post Anesthesia Care Unit
Secondary
· up to 90 minutes
comparison between alfentanil vs placebo - Subject questionnaire with scale: 0 -10 - with 10 being the worst
| Group | Value | 95% CI |
|---|---|---|
| Alfentanil | 2 | ± 2.887 |
| Placebo | 2.467 | ± 3.038 |
Satisfaction With the Anesthetic Post-procedure
Secondary
· up to 90 minutes
comparison between alfentanil vs placebo - Subject questionnaire with scale: 0-10 - with 10 being the worst
| Group | Value | 95% CI |
|---|---|---|
| Alfentanil | 8 | ± 2.449 |
| Placebo | 8.033 | ± 2.505 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 24 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Alfentanil
Serious: 1/87 (1%)
Deaths: 1/87
Placebo
Serious: 1/87 (1%)
Deaths: 1/87
Serious adverse events (1 terms)
| Reaction | System | Alfentanil | Placebo |
|---|---|---|---|
| Suicide | Social circumstances | — | — |
Other adverse events (1 terms — click to expand)
| Reaction | System | Alfentanil | Placebo |
|---|---|---|---|
| Suicide | Social circumstances | — | — |
Most-reported serious reactions: Suicide.
Data from ClinicalTrials.gov NCT03359395 adverse events section.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03359395
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Wake Forest University Health Sciences trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03359395 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
- Last refreshed: 8 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03359395.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing