StressNCT00948181

Evaluation of Plasma Catecholamine Concentration During Surgery

An observational study of Stress, run by Kliniken Essen-Mitte at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

Stress during surgery leads to significant increase in plasma catecholamine concentrations in surgeons, anesthesiologists, and patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stress
How many people: 8 participants
Where: 1 siteGermany
Study dates: Jun 2009to Sep 2010
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

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).

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

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Prof. Dr. Harald Groeben
Essen, 45136

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Conditions: Stress
Keywords: Epinephrine, Norepinephrine, normetanephrine, Catecholamine concentrations during surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00948181
Study group	Role	What they receive
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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Sep 2010

First posted29 Jul 2009 (estimated)
Study startJun 2009
Primary completionJul 2010 (estimated)
Study completionSep 2010 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for StressStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 8 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00948181
Sponsor's protocol ID: 2009061
Status last verified: Jul 2009
First submitted: 28 Jul 2009
Last updated: 29 Jul 2009
Results posted: No
Data monitoring committee: No

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.
PubMed 16498054
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.
PubMed 8541435

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Stress Hormone Concentration During the Resection of Pheochromocytoma. Comparison of Surgeon - Anesthesiologist - Patient
ClinicalTrials.gov ID: NCT00948181
Acronym / sponsor ID: 2009061
Conditions: Stress
Keywords: Epinephrine, Norepinephrine, normetanephrine, Catecholamine concentrations during surgery
Study type: Observational
Recruitment status: Unknown status
Enrolment: 8 participants (estimated)
Lead sponsor: Kliniken Essen-MitteUniversity, hospital or other
Collaborators: Universität Duisburg-Essen
Study start: Jun 2009
Primary completion: Jul 2010 (estimated)
Study completion: Sep 2010 (estimated)
First posted: 29 Jul 2009 (estimated)
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.

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Not reported in the source record.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2009.
Background: PubMed 16498054Unger 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.
Background: PubMed 8541435Schuttler 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.

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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.

Harald Groeben, M.D. principal investigator

Kliniken Essen-Mitte

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Stress, run by Kliniken Essen-Mitte at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 29 Jul 2009. 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 Germany. 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.

Are results available for this study?

Results are not available in the source record.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00948181, which also lists 2 linked publications.

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 29 Jul 2009; AzTrials last refreshed its copy on 29 Oct 2026.