PheochromocytomaPhase 2NCT04320589
the Effect of Dexmedetomidine and Magnesium Sulfate in Open Resection of Pheochromocytoma
A Phase 2 study testing Dexmedetomidine and General anesthetic in people with Pheochromocytoma, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 69 years
- Conditions the study is for
- Pheochromocytoma
- What is being tested?
- Dexmedetomidine and General anesthetic
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2019to 30 Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia and Pain medicine.National Cancer Institute
Cairo, 11796
About this study
Official title: The Perioperative Use of Dexmedetomidine and Magnesium Sulfate Compared With Traditional Anesthetic Technique for Open Resection of Pheochromocytoma.
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.
Read the detailed description
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.The anesthetic management of Pheo during surgical resection is usually challenging \& faces many cardiovascular risks as tachycardia, arrhythmias, severe hypertension \& may be pulmonary edema \& profound hypotension after surgical devascularization of the tumor. These dangerous events are sequelae of catecholamine excess and often are refractory to management . The proper anesthetic control is based on the use of α₁ \& β-adrenergic blockers (phenoxy-benzamine, phentolamine, propranolol, labetalol) and vasodilators such as glycerine trinitrate (GTN) \& sodium nitroprusside (SNP) .The rational of using magnesium sulphate MgSo₄ infusion to control catecholamine levels \& catecholamine-related crisis has been established in several clinical emergencies such as severe tetanus \& preoperative management of pre-eclampsia \& eclampsia . MgSo₄ beneficial cardiovascular effects may be attributed to its ability to reduce catecholamine release from the adrenal medulla \& to reduce α-adrenergic receptors sensitivity to catecholamines . MgSo₄ is also a direct vasodilator \& a potent anti-arrhythmic drug particularly with high circulatory catecholamine level . The safety of MgSo₄ in the routine clinical range of 2-4 mmol/Liter is well settled in many clinical works.
There is strong evidence that the sympathetic nervous system is intact in Pheo patients \& neurons-released noradrenaline plays a fundamental role in blood pressure BP regulation. Dexmedetomidine is a short acting \& highly selective central α₂-agonist that inhibits neuronal firing \& thereby induces analgesia, anxiolysis, bradycardia \& hypotension. It has been tried to attenuate the sympathetic pressor effect of tracheal intubation, cardiac surgeries \& emergence from anesthesia .The unique adventitious anesthetic pharmacology induces preoperative sedation, intra-operative hemodynamic stability beside reducing the anesthetic requirements and adding to post-operative analgesia . Its peri-operative use has been suggested in both pediatric \& adult patients of Pheo.
In this prospective work,the investigators tried to compare the peri-operative hemodynamic course of Dexmedetomidine \& 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 this recommended technique on the peri-operative hemodynamic stability \& controlling the hypertensive crisis during tumor manipulation.
- Conditions
- Pheochromocytoma
- Being tested
- Dexmedetomidine, General anesthetic
- Medical subject headings
- Pheochromocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called drug group
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
General anestheticDrug
Also called control group
- 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]
| Study group | Role | What they receive |
|---|---|---|
| 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] Receives: 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 Receives: Drug: General anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of Hypertensive crisis
rise of B.P. more than 20% of base line
Measured: 12 hours follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start30 Jun 2019
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Hanafy Shaker, National Cancer Institute, Egypt
- Investigators
- Ehab H Shaker, MD, Principal investigator, National Cancer Institute- Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320589
- Sponsor's protocol ID
- Ehab - Hegazy pheochromocytoma
- Status last verified
- Aug 2021
- First submitted
- 22 Mar 2020
- Last updated
- 1 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After total completion of the study
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Perioperative Use of Dexmedetomidine and Magnesium Sulfate Compared With Traditional Anesthetic Technique for Open Resection of Pheochromocytoma.
- ClinicalTrials.gov ID
- NCT04320589
- Acronym / sponsor ID
- Ehab - Hegazy pheochromocytoma
- Conditions
- Pheochromocytoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.The anesthetic management of Pheo during surgical resection is usually challenging \& faces many cardiovascular risks as tachycardia, arrhythmias, severe hypertension \& may be pulmonary edema \& profound hypotension after surgical devascularization of the tumor. These dangerous events are sequelae of catecholamine excess and often are refractory to management . The proper anesthetic control is based on the use of α₁ \& β-adrenergic blockers (phenoxy-benzamine, phentolamine, propranolol, labetalol) and vasodilators such as glycerine trinitrate (GTN) \& sodium nitroprusside (SNP) .The rational of using magnesium sulphate MgSo₄ infusion to control catecholamine levels \& catecholamine-related crisis has been established in several clinical emergencies such as severe tetanus \& preoperative management of pre-eclampsia \& eclampsia . MgSo₄ beneficial cardiovascular effects may be attributed to its ability to reduce catecholamine release from the adrenal medulla \& to reduce α-adrenergic receptors sensitivity to catecholamines . MgSo₄ is also a direct vasodilator \& a potent anti-arrhythmic drug particularly with high circulatory catecholamine level . The safety of MgSo₄ in the routine clinical range of 2-4 mmol/Liter is well settled in many clinical works.
There is strong evidence that the sympathetic nervous system is intact in Pheo patients \& neurons-released noradrenaline plays a fundamental role in blood pressure BP regulation. Dexmedetomidine is a short acting \& highly selective central α₂-agonist that inhibits neuronal firing \& thereby induces analgesia, anxiolysis, bradycardia \& hypotension. It has been tried to attenuate the sympathetic pressor effect of tracheal intubation, cardiac surgeries \& emergence from anesthesia .The unique adventitious anesthetic pharmacology induces preoperative sedation, intra-operative hemodynamic stability beside reducing the anesthetic requirements and adding to post-operative analgesia . Its peri-operative use has been suggested in both pediatric \& adult patients of Pheo.
In this prospective work,the investigators tried to compare the peri-operative hemodynamic course of Dexmedetomidine \& 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 this recommended technique on the peri-operative hemodynamic stability \& controlling the hypertensive crisis during tumor manipulation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | Active comparator | Drug: DexmedetomidineTraditional 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] |
| Dexmedetomidine | Active comparator | Drug: General anestheticDexmedetomidine-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 |
Who may qualify
- Ages
- 12 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: drug groupwhich 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 Anesthesia |
| General anestheticAlso: control group1) 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] | Drug | Dexmedetomidine |
Primary outcome
The rate of Hypertensive crisis
Time frame: 12 hours follow up
rise of B.P. more than 20% of base line
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Dexmedetomidine as intravenous sedating agentLink provided by the sponsor.
- Individual participant dataSharing planned: No. After total completion of the study
Related trials for Pheochromocytoma
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Active, not recruitingObservational study
Natural History Study of Children and Adults With Medullary Thyroid Cancer
Medullary Thyroid Cancer
RecruitingObservational study
Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions
Pheochromocytoma, Paraganglioma
RecruitingObservational study
Von Hippel-Lindau (VHL): Clinical Manifestations, Diagnosis, Management and Molecular Bases of Inherited Renal and Other Urologic Malignant Disorders
Kidney Cancer, Urologic Malignant Disorders
RecruitingPhase 2
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ehab H Shaker, MD principal investigator
National Cancer Institute- Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexmedetomidine and General anesthetic in people with Pheochromocytoma, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of Hypertensive crisis (time frame: 12 hours follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.