drugset / Trial / NCT04320589

the Effect of Dexmedetomidine and Magnesium Sulfate in Open Resection of Pheochromocytoma

NCT04320589

Phase 2 Completed 30 enrolled National Cancer Institute, Egypt
RandomizedParallel-groupSingle-blindPrevention

Summary

Pheochromocytoma (pheo) is a catecholamine secreting tumor arising from chromaffin cells of the adrenal medulla in 90% of cases \& in 10% is extra-adrenal arising from the sympathetic chain. It is malignant in 10% of cases, bilateral in 10% of patients \& 10% of all pheo are inherited (Familial Pheo) as autosomal dominant either alone or as a part of multiple endocrine neoplasia (MEN) syndrome.In this prospective work, the investigators will try to compare the peri-operative hemodynamic course of Dexmedetomidine \& magnesium sulphate (MgSo₄) infused patients with the traditional anesthetic technique (α₁ \& β-adrenergic blockers plus vasodilators) during open surgical resection of Pheo. The investigators are aiming to check the safety \& efficacy of the recommended technique on the peri-operative hemodynamic stability \& controlling the hypertensive crisis during tumor manipulation.

Timeline

Start
2019-06-30
Primary completion
2021-08-30
Completion
2021-08-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 0.2 ug/kg
Comparator Dexmedetomidine Other / unclassified 0.7 ug/kg
Comparator Magnesium Sulfate Other / unclassified 40 mg/kg Intravenous
Comparator Atenolol Other / unclassified 25 mg Oral
Comparator Atenolol Other / unclassified 100 mg Oral
Comparator Bisoprolol Other / unclassified 2.5 mg Oral
Comparator Bisoprolol Other / unclassified 20 mg Oral
Comparator Candesartan cilexetil Unknown 4 mg Oral
Comparator Candesartan cilexetil Unknown 16 mg Oral
Comparator Labetalol Small molecule 200 mg Oral
Comparator Labetalol Small molecule 600 mg Oral
Comparator Prazocin Unknown 0.5 mg Oral
Comparator Prazocin Unknown 20 mg Oral
Comparator Propranolol Small molecule 10 mg Oral
Comparator Propranolol Small molecule 360 mg Oral
Comparator Ramipril Small molecule 2.5 mg Oral
Comparator Ramipril Small molecule 10 mg Oral

Indications