Pheochromocytoma and paraganglioma (PPGL) are rare neuroendocrine tumors originating from catecholamine producing chromaffin cells in the adrenal medulla and extra-adrenal paraganglia. The overall age-standardized incidence rate is 0.18 per 100,000 person-years in Korea.
The definitive treatment of PPGL is surgical excision of tumor. However, surgery is associated with a high risk of perioperative hemodynamic instability (HI). To avoid perioperative HI in patients diagnosed with PPGL, preoperative management including routine use of alpha blockade and volume expansion has been advocated by several guidelines.
While unstable hypertension and tachycardia should be controlled in patients with PPGL, there is controversial that all patients diagnosed with PPGL should undergo preoperative pharmacological treatment, especially alpha blockade. The most important risk of preoperative alpha blockade use is perioperative hypotension.
A recent study reported that patients diagnosed with PPGL postoperatively may have no further higher risk of intraoperative hypertension than those diagnosed preoperatively despite insufficient preoperatively management of PPGL.
Therefore, it is a very important to study the relationship between HI and preoperative alpha blockade in normotensive patients diagnosed with PPGL. The aim this study is to analyze the effect and safety of omitting preoperative alpha-adrenergic blockade for normotensive pheochromocytoma through a prospective randomized controlled trial. The patients is divided into two groups. The patients in control group take a phenoxybenzamine at least 2 to 5 weeks before surgery. The patients in case group do not take a phenoxybenzamine.
Primary outcome is to evaluate the percentage of time during surgery with systolic blood pressure more than 160mmHg or average blood pressure less than 60mmHg. And secondary outcomes are to evaluate hemodynamic instability in preoperative ward and postoperative ward.
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
Patients under 18 or over 70 years old
Pregnant women
Patients with bilateral pheochromocytoma
Patients suspected of malignant pheochromocytoma/paraganglioma or distant metastasis
Parallel
Phenoxybenzamine
DrugPatients in sham comparator group take a phenoxybenzamine at least 2 to 5 weeks before surgery. If blood pressure is more than 130/80 mmHg in the sitting position, the patient will take a more amount of phenoxybenzamine. If blood pressure is less than 90 mmHg in the standing position, the patient will take a less amount of phenoxybenzamine. In active comparator group, there is no drug to be taken.
The effect and safety of omitting preoperative alpha blockade during surgery
Percentage of time during the surgery with systolic blood pressure \> 160mmHg or average blood pressure \< 60mmHg
The effect and safety of omitting preoperative alpha blockade during surgery
1. Percentage of the surgery time greater than 100 times per pulse minute 2. Average systolic/diastolic blood pressure in millimeters of mercury and pulse in beats each minutes during surgery 3. Types and amount of antihypertensive drugs in mg per day during surgery 4. Types and amount of vasopressor drugs in mg per day during surgery
The effect and safety of omitting preoperative alpha blockade before surgery
1. The number of times systolic blood pressure more than 130 mmHg and diastolic blood pressure more than 80mmHg in the preoperative ward 2. The number of times of pulse rate per minute more than 80 times in the preoperative ward
The effect and safety of omitting preoperative alpha blockade after surgery
1. The number of times of average blood pressure less than 60mmHg in postoperative ward 2. Average blood pressure in postoperative ward 3. Types and amount of antihypertensive drugs in mg per day after surgery 4. Types and amount of vasopressor drugs in mg per day after surgery
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