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

NCT04320589 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-09-01

No results posted yet for this study

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.

Conditions

  • Pheochromocytoma

Interventions

DRUG

Dexmedetomidine

which in addition to the orally prescribed drugs; on admission to the ICU, the Pheo-patient has serum-Mg level measurement \& a bolus of 40 mg/kg MgSo₄ is given I.V. \& may be repeated until the therapeutic level of MgSo₄ 2-4 mmol/Liter is reached (7\&10). Dexmedetomidine sedation is started the evening prior to surgery by loading dose of 1µg/Kg followed by 0.2-0.7 µg/Kg/hour according to each patient

DRUG

General anesthetic

1\) Traditional group in which the patients̕ hemodynamic adjustment will be conducted using orally or IV α₁ \& β-adrenergic blockers \[Prazocin (minipress): 0.5-20 mg/day, Propranolol (Inderal) :10-360 mg/day, Bisoprolol (Concor): 2.5-20 mg/day, Atenolol (Tenormin): 25-100 mg/day \&/or Labetalol (Trandate)200-600 mg/day, ACI \& ACRB e.g. Tritace 2.5-10 mg/day \& Atacand 4-16 mg/day\]

Sponsors & Collaborators

  • National Cancer Institute, Egypt

    lead OTHER

Principal Investigators

  • Ehab H Shaker, MD · National Cancer Institute- Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04320589 on ClinicalTrials.gov