Omitting preoperative alpha-blockade for normotensive pheochromocytoma
Official title: A Pilot Study for Randomized Controlled Trial on the Effect and Safety of Omitting Preoperative Alpha-adrenergic Blockade for Normotensive Pheochromocytoma
Run by Seoul National University Hospital · NCT05702944 · Data updated 2026-11-12
This study is testing whether skipping a common medication before surgery can help patients with certain tumors avoid low blood pressure during and after their operation without putting them at risk.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years to 70 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | January 18, 2023 |
| Main results expected | August 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | June 12, 2025 |
| Trial ID | NCT05702944 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 19 to 70 years undergoing unilateral total adrenalectomy for normotensive pheochromocytoma or paraganglioma.
✕Probably not a fit
Patients with hypertension, those requiring intensive care, or those with a history of severe cardiovascular issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the safety and effects of not using preoperative alpha-adrenergic blockade in patients undergoing surgery for normotensive pheochromocytoma and paraganglioma. The study aims to determine if avoiding this routine treatment can reduce the risk of perioperative hypotension without compromising patient safety. Participants will be monitored for hemodynamic stability during and after their surgical procedures. The trial focuses on patients who meet specific criteria, including age and health status, to ensure a controlled environment for assessing outcomes.
Why it matters
Potential benefit: If successful, this approach could lead to safer surgical procedures for patients with normotensive pheochromocytoma, reducing the need for preoperative medications.
How similar studies have gone: While there is ongoing debate regarding preoperative management in similar cases, this specific approach of omitting alpha-blockade is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 19 to 70 years old * Patients who consented to the study and obtained consent for the study * Patients undergoing unilateral total adrenalectomy due to normotensive pheochromocytoma/paraganglioma with less than five times of upper limits of serum metanephrine Exclusion Criteria: * Patients under 18 or over 70 years old * Pregnant women * Patients with bilateral pheochromocytoma * Patients suspected of malignant pheochromocytoma/paraganglioma or distant metastasis * Patients requiring preoperative intensive care unit due to severe hemodynamic instability * Patients with hypertension (the blood pressure measured more than two times is constantly greater than 140/90 mmHg) or already taking a antihypertensive medication * Patients with a history of coronary artery disease * Patients with a history of arrhythmia (atrial fibrillation, Paroxysmal supraventricular tachycardia) * Patients with a history of cerebrovascular disease (cerebral aneurysm, cerebral infarction, cerebral hemorrhage) * Patients judged unsuitable by the person in charge of the clinical trial
Where it's running
-
Seoul National University Hospital
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Su-Jin Kim, M.D., Ph.D — Seoul National University Hospital
- Study coordinator: Su-Jin Kim, M.D., Ph.D.
- Email: su.jin.kim.md@gmail.com
- Phone: +82-2-2072-7208
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.