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Evaluation of Plasma Catecholamine Concentration During Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Kliniken Essen-Mitte.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Universität Duisburg-Essen
Information provided by:
Kliniken Essen-Mitte
ClinicalTrials.gov Identifier:
NCT00948181
First received: July 28, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

Stress during surgery leads to significant increase in plasma catecholamine concentrations in surgeons, anesthesiologists, and patients.


Condition
Stress

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Stress Hormone Concentration During the Resection of Pheochromocytoma. Comparison of Surgeon - Anesthesiologist - Patient

Resource links provided by NLM:

MedlinePlus related topics: Pheochromocytoma
U.S. FDA Resources

Further study details as provided by Kliniken Essen-Mitte:

Biospecimen Retention:   Samples Without DNA

Venous blood will be drawn from the surgeon, anesthesiologist and from 8 patients to determine plasma catecholamine concentrations. Only plasma will be used for measurements.


Estimated Enrollment: 8
Study Start Date: June 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Surgeon
To detect the degree of intraoperative stress, venous blod will be drawn from one surgeon during 8 pheochromocytoma resections.
Anesthesiologist
To detect the degree of intraoperative stress, venous blood will be drawn from one anesthesiologist during 8 pheochromocytoma resections.
Patients with pheochromocytoma
Venous blood will be drawn from 8 patients with pheochromocytoma during tumor resection.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

Inclusion Criteria: Patients with pheochromocytoma (Older than 18 years) -

Exclusion Criteria: Patients younger than 18 years. Conservative treatment.

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948181

Locations
Germany
Prof. Dr. Harald Groeben
Essen, Germany, 45136
Sponsors and Collaborators
Kliniken Essen-Mitte
Universität Duisburg-Essen
Investigators
Principal Investigator: Harald Groeben, M.D. Kliniken Essen-Mitte
  More Information

Publications:

Responsible Party: Prof. Dr. Harald Groeben, Kliniken Essen-Mitte
ClinicalTrials.gov Identifier: NCT00948181     History of Changes
Other Study ID Numbers: 2009061
Study First Received: July 28, 2009
Last Updated: July 28, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Kliniken Essen-Mitte:
Epinephrine, Norepinephrine, normetanephrine
Catecholamine concentrations during surgery

ClinicalTrials.gov processed this record on June 18, 2013