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Anesthesia Management of Retroperitoneal Adrenalectomies

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Kliniken Essen-Mitte.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Kliniken Essen-Mitte
ClinicalTrials.gov Identifier:
NCT00894335
First received: May 6, 2009
Last updated: June 27, 2011
Last verified: May 2009
  Purpose
This study is a prospective, perioperative evaluation of hemodynamic and respiratory parameters in patients undergoing retroperitoneoscopic adrenalectomies.

Condition
Adrenal Tumors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anesthesiological Management of Hemodynamics and Gas Exchange for Retroperitoneal Adrenalectomies

Further study details as provided by Kliniken Essen-Mitte:

Primary Outcome Measures:
  • Arterial-alveolar Carbon dioxide Difference [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perioperative maximal mean arterial pressure [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: May 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Pheochromocytoma
2
Conn-Syndrome
3
Cushing disease
4
Metastasis
5
Non-functional tumor

Detailed Description:
Due to their underlying disease, patients with adrenal tumors are prone to episodes of hyper- and hypotension. Furthermore, excessive hypercarbia and an increased arterial-alveolar CO2 difference can be seen during these operations.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with adrenal tumors scheduled for retroperitoneal adrenalectomies
Criteria

Inclusion Criteria:

  • Patients with an adrenal tumor

Exclusion Criteria:

  • Age below 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894335

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

Publications:
Responsible Party: Harald Groeben, Prof. Dr., Department of Anesthesiology and CCM , Clinics Essen-Mitte
ClinicalTrials.gov Identifier: NCT00894335     History of Changes
Other Study ID Numbers: retroper adrenal 
Study First Received: May 6, 2009
Last Updated: June 27, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Kliniken Essen-Mitte:
retroperitoneoscopic adrenalectomy
intraoperative arterial-alveolar Carbon dioxide Difference

Additional relevant MeSH terms:
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adrenal Gland Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on December 09, 2016