Phase 3
N=39
Preoperative Alpha Blockade for Pheochromocytoma
Pheochromocytoma · Paraganglioma
Bottom Line
View on ClinicalTrials.gov: NCT03176693 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Hemodynamic Instability — 14; 13 percentage of total operative time — p=.56
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Phenoxybenzamine (Drug); Doxazosin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemodynamic Instability |
14; 13 | .56 |
| SECONDARY Mortality |
0; 0 | — |
| SECONDARY Daily Cost of Drug |
442.20; 5.06 | — |
| SECONDARY Quality of Life- Physical Functioning, Role Limitations Due to Physical Problems, Bodily Pain, General Health Perceptions, Vitality, Social Functioning, Role-limitations Due to Emotional Problems, and Mental Health |
— | — |
| SECONDARY Morbidity as Assessed by Occurrence of Adverse Events |
0; 0 | — |
| SECONDARY Participants Admitted to Post-operative Intensive Care Unit (ICU) |
2; 1 | — |
Summary
Pheochromocytoma is a rare, catecholamine (ex. adrenaline) secreting tumor that requires preoperative alpha blockade to minimize intraoperative hemodynamic instability, thereby reducing intra- and postoperative morbidity and mortality. Phenoxybenzamine is a non-selective alpha blocker that is significantly more expensive and is associated with increased adverse effects in comparison with selective alpha blockers such as doxazosin. Retrospective studies show minimal differences in hemodynamic instability and no differences in postoperative morbidity and mortality between selective vs. non-selective alpha blockers. This study is a randomized controlled trial that will compare hemodynamic instability, morbidity, mortality, cost, and quality of life between patients blocked with phenoxybenzamine vs. doxazosin.
Eligibility Criteria
Inclusion Criteria
- Adults with pheochromocytoma / paraganglioma undergoing surgical resection
Exclusion Criteria
- Children < 18 years
Data sourced from ClinicalTrials.gov (NCT03176693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.