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Anesthesia Management of Retroperitoneal Adrenalectomies

The recruitment status of this study is unknown because the information has not been verified recently.
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
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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

Contacts
Contact: Harald Groeben, Prof., M.D. ##49 201 174 ext 31109 h.groeben@kliniken-essen-mitte.de

Locations
Germany
Clinics Essen-Mitte Recruiting
Essen, Germany, 45136
Contact: Harald Groeben, Prof, M.D.     ##49 201 174 ext 31109     h.groeben@kliniken-essen-mitte.de    
Contact: Harald Groeben, Prof, M.D.     ##49 201 174 ext 31109     h.groeben@klinken-essen-mitte.de    
Principal Investigator: Harald Groeben, Prof., M.D.            
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 May 16, 2013