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

NCT04320589 | Completed Phase 2

• 1 other identifier: Ehab - Hegazy pheochromocytoma
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The rate of Hypertensive crisis

  rise of B.P. more than 20% of base line

  12 hours follow up

Study Arms (2)

General Anesthesia

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine-Magnesium Sulfate (Dex-MgSo₄) group: in 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. 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

Interventions

Dexmedetomidine DRUG

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

Also known as: drug group

General Anesthesia

General anesthetic DRUG

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

Also known as: control group

Dexmedetomidine

Eligibility Criteria

• Age: 12 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 12-69 years
• ASA physical status I \&II
• Surgically diagnosed pheochromocytoma, "unilateral or bilateral, adrenal or extra-adrenal". Diagnosis is confirmed radiologically with or without laboratory Vanillyl Mandelic Acid (VMA) level.
• Accepted Echo-heart data (EF ≥ 55%, no serious valve lesion) apart from hypertensive concentric ventricular hypertrophy \& diastolic dysfunction grade I \&II.

You may not qualify if:

• Extremes of age
• ASA III \& IV
• History of cardiac (MI \& IHD) or cerebral (CVS) events
• History of major reaction to the used drugs
• History of major muscle, endocrinal or hematologic disorders
• Pregnant and lactating women
• Poor Echo-heart findings e.g. EF \< 55%, severe valve lesions \& severe pulmonary hypertension.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Department of Anesthesia and Pain medicine.National Cancer Institute

Cairo, 11796, Egypt

Location

Related Links

• Dexmedetomidine as intravenous sedating agent

MeSH Terms

Conditions

Pheochromocytoma

Interventions

Dexmedetomidine; Anesthetics, General; Control Groups

Condition Hierarchy (Ancestors)

Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ehab H Shaker, MD

  National Cancer Institute- Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia ,critical care and pain medicine

Study Record Dates

• First Submitted: March 22, 2020
• First Posted: March 25, 2020
• Study Start: June 30, 2019
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)