Phaeochromocytoma CrisisNCT05102058
Magnesium and Dexmedetomidine in Pheochromocytoma
An observational study of Phaeochromocytoma Crisis and Hemodynamic Instability, run by Istanbul University.
Trial summary
Anesthesia management of pheochromocytoma excision surgery is associated with severe hemodynamic fluctuations.The objective of this study was to compare the hypertensive episodes requiring sodium nitroprusside administration between the group treated with magnesium-dexmedetomidine and conventional group in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Phaeochromocytoma Crisis, Hemodynamic Instability
- What is being tested?
- Magnesium-Dexmedetomidine
- Type of treatment
- Pill or oral medicine
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 1 Mar 2020
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients' data who were aged 18-75, had the American Society of Anesthesiologists classification (ASA) 1-3 and high urinary catecholamine or metabolites. Patients with tumor sizes < 5 cm and body mass index (BMI) <35 kg.m-2 were examined, who were evaluated according to Endocrine Society Practice Guideline and provided the Roizen criteria.
Who may be able to join
- American Society of Anesthesiologists classification (ASA) 1-3
- high urinary catecholamine or metabolites
- tumor sizes < 5 cm
- body mass index (BMI) <35 kg/m2
Who cannot join
- open surgery
- bilateral masses
- tumor larger than 5 cm
- incomplete data
About this study
Official title: Magnesium and Dexmedetomidine Combination Reduces Sodium Nitroprusside Requirement in Laparoscopic Pheochromocytoma
Anesthesia management of pheochromocytoma excision surgery is associated with severe hemodynamic fluctuations.The objective of this study was to compare the hypertensive episodes requiring sodium nitroprusside administration between the group treated with magnesium-dexmedetomidine and conventional group in pheochromocytoma.
- Conditions
- Phaeochromocytoma Crisis, Hemodynamic Instability
- Being tested
- Magnesium-Dexmedetomidine
- Keywords
- Magnesium, Dexmedetomidine, Nitroprusside, Pheochromocytoma
- Medical subject headings
- Pheochromocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium-DexmedetomidineDrug
Received oral 300 mg magnesium one week before surgery and magnesium-dexmedetomidine combination perioperatively
| Study group | Role | What they receive |
|---|---|---|
| Conventional group (GC) | Not receive perioperative additional medication. | |
| Magnesium-dexmedetomidine therapy group (GMD) | Received oral 300 mg magnesium one week before surgery and magnesium-dexmedetomidine combination perioperatively. Receives: Drug: Magnesium-Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sodium nitroprusside (SNP) requirement
intraoperative hypertensive episodes requiring SNP therapy
Measured: intraoperative period
Secondary outcomes (1)
vasoactive therapy
hemodynamic fluctuations (hypotension, tachycardia, severe hypertensive crisis) which needed vasoactive therapy.
Measured: intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Jan 2011
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phaeochromocytoma CrisisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nukhet Sivrikoz, Istanbul University
- Investigators
- Nükhet Sivrikoz, MD, Principal investigator, Attending anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102058
- Sponsor's protocol ID
- 2021/42
- Status last verified
- Oct 2021
- First submitted
- 20 Oct 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium and Dexmedetomidine Combination Reduces Sodium Nitroprusside Requirement in Laparoscopic Pheochromocytoma
- ClinicalTrials.gov ID
- NCT05102058
- Acronym / sponsor ID
- 2021/42
- Conditions
- Phaeochromocytoma Crisis, Hemodynamic Instability
- Keywords
- Magnesium, Dexmedetomidine, Nitroprusside, Pheochromocytoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 1 Nov 2021 (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.
Anesthesia management of pheochromocytoma excision surgery is associated with severe hemodynamic fluctuations.The objective of this study was to compare the hypertensive episodes requiring sodium nitroprusside administration between the group treated with magnesium-dexmedetomidine and conventional group in pheochromocytoma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional group (GC) | – | –Not receive perioperative additional medication. |
| Magnesium-dexmedetomidine therapy group (GMD) | – | Drug: Magnesium-DexmedetomidineReceived oral 300 mg magnesium one week before surgery and magnesium-dexmedetomidine combination perioperatively. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients' data who were aged 18-75, had the American Society of Anesthesiologists classification (ASA) 1-3 and high urinary catecholamine or metabolites. Patients with tumor sizes < 5 cm and body mass index (BMI) <35 kg.m-2 were examined, who were evaluated according to Endocrine Society Practice Guideline and provided the Roizen criteria.
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists classification (ASA) 1-3
- high urinary catecholamine or metabolites
- tumor sizes < 5 cm
- body mass index (BMI) <35 kg/m2
Key exclusion criteria (4 listed)
- open surgery
- bilateral masses
- tumor larger than 5 cm
- incomplete data
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 |
|---|---|---|
| Magnesium-DexmedetomidineReceived oral 300 mg magnesium one week before surgery and magnesium-dexmedetomidine combination perioperatively | Drug | Magnesium-dexmedetomidine therapy group (GMD) |
Primary outcome
Sodium nitroprusside (SNP) requirement
Time frame: intraoperative period
intraoperative hypertensive episodes requiring SNP therapy
1 secondary outcome
vasoactive therapy
Time frame: intraoperative period
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 Nov 2021.
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.
Nükhet Sivrikoz, MD principal investigator
Attending anesthesiologist
Questions about this trial
What is this clinical trial studying?
An observational study of Phaeochromocytoma Crisis and Hemodynamic Instability, run by Istanbul University.
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 4 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 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Sodium nitroprusside (SNP) requirement (time frame: intraoperative period). 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 Nov 2021.