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A Pilot study for randomized controlled trial on the effect and safety of omitting preoperative alpha-adrenergic blockade for normotensive pheochromocytoma

A Pilot study for randomized controlled trial on the effect and safety of omitting preoperative alpha-adrenergic blockade for normotensive pheochromocytoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0012161
Enrollment
24
Registered
2026-06-23
Start date
2023-01-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : In the control group, patients will take an oral alpha-adrenergic blocker (phenoxybenzamine or doxazosin) for a minimum of 2 weeks and up to 5 weeks prior to surgery, whereas patients in the in

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A. Patients aged 19 to 70 years, inclusive. B. Patients who have provided voluntary consent to participate in the study, with a duly executed informed consent form obtained. C. Patients diagnosed with pheochromocytoma or paraganglioma, who demonstrate normotensive blood pressure (=140/90 mmHg) and plasma metanephrine levels less than five times the upper limit of normal, and who are scheduled to undergo unilateral total adrenalectomy.

Exclusion criteria

Exclusion criteria: A. Patients aged 18 years or younger, or older than 70 years. B. Pregnant women. C. Patients with bilateral pheochromocytoma. D. Patients with malignant pheochromocytoma or those with suspected metastasis. E. Patients requiring preoperative intensive care unit admission due to severe hemodynamic instability. F. Patients with hypertension (defined as persistently elevated blood pressure =140/90 mmHg on at least two measurements, or current use of antihypertensive medication). G. Patients with a history of coronary artery disease. H. Patients with a history of arrhythmia, including atrial fibrillation or paroxysmal ventricular tachycardia. I. Patients with a history of cerebrovascular disease, including cerebral aneurysm, cerebral infarction, or intracerebral hemorrhage. J. Patients otherwise deemed inappropriate for study participation at the discretion of the clinical investigators.

Design outcomes

Primary

MeasureTime frame
The percentage of total operative time during which the systolic blood pressure exceeds 160 mmHg or the mean arterial pressure falls below 60 mmHg.

Secondary

MeasureTime frame
Percentage of total operative time during which the heart rate exceeds 100 beats per minute;Number of episodes of systolic blood pressure =130 mmHg or diastolic blood pressure =80 mmHg in the preoperative ward;Number of episodes in which the heart rate is outside 80 beats per minute in the preoperative ward;Number of episodes of mean arterial pressure <60 mmHg in the postoperative ward ;Mean intraoperative systolic blood pressure, diastolic blood pressure, and heart rate;Mean blood pressure in the preoperative and postoperative wards;Mean blood pressure in the postoperative wards;Types and total doses of antihypertensive agents administered during and after surgery;Types and total doses of vasopressor agents administered during and after surgery

Countries

Korea, Republic of

Contacts

Public ContactSookkyeong Seo

Seoul National University Hospital

seo92@snu.ac.kr+82-2-6072-5056

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jul 3, 2026