- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00948181
Evaluation of Plasma Catecholamine Concentration During Surgery
July 28, 2009 updated by: Kliniken Essen-Mitte
Evaluation of Stress Hormone Concentration During the Resection of Pheochromocytoma. Comparison of Surgeon - Anesthesiologist - Patient
Stress during surgery leads to significant increase in plasma catecholamine concentrations in surgeons, anesthesiologists, and patients.
Study Overview
Status
Unknown
Conditions
Detailed Description
Hypothesis: Resection of pheochromocytomas can lead to more than normal stress in surgeons and because of abrupt hemodynamic changes in patients as well in anesthesiologists.
Measurements of catecholamine concentrations at baseline, prior to surgery during and after surgery, are to be performed to test this hypothesis.
Study Type
Observational
Enrollment (Anticipated)
8
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Essen, Germany, 45136
- Prof. Dr. Harald Groeben
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The population consists of 8 patients with pheochromocytoma scheduled for tumor resection, one surgeon (with the experience of more than 50 pheochromocytoma resections) and one anesthesiologist (with the experience of more than 50 pheochromocytoma resections).
Description
Inclusion Criteria: Patients with pheochromocytoma (Older than 18 years) -
Exclusion Criteria: Patients younger than 18 years. Conservative treatment.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Surgeon
To detect the degree of intraoperative stress, venous blod will be drawn from one surgeon during 8 pheochromocytoma resections.
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Anesthesiologist
To detect the degree of intraoperative stress, venous blood will be drawn from one anesthesiologist during 8 pheochromocytoma resections.
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Patients with pheochromocytoma
Venous blood will be drawn from 8 patients with pheochromocytoma during tumor resection.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Unger N, Pitt C, Schmidt IL, Walz MK, Schmid KW, Philipp T, Mann K, Petersenn S. Diagnostic value of various biochemical parameters for the diagnosis of pheochromocytoma in patients with adrenal mass. Eur J Endocrinol. 2006 Mar;154(3):409-17. doi: 10.1530/eje.1.02097.
- Schuttler J, Westhofen P, Kania U, Ihmsen H, Kammerecker S, Hirner A. [Quantitative assessment of catecholamine secretion as a rational principle of anesthesia management in pheochromocytoma surgery]. Anasthesiol Intensivmed Notfallmed Schmerzther. 1995 Oct;30(6):341-9. doi: 10.1055/s-2007-996507. German.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Anticipated)
July 1, 2010
Study Completion (Anticipated)
September 1, 2010
Study Registration Dates
First Submitted
July 28, 2009
First Submitted That Met QC Criteria
July 28, 2009
First Posted (Estimate)
July 29, 2009
Study Record Updates
Last Update Posted (Estimate)
July 29, 2009
Last Update Submitted That Met QC Criteria
July 28, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- 2009061
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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