Spinal Anesthesia and Blood Pressure - Full Text View

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00435422

Purpose

The effect of individualized fluid optimization prior to spinal anesthesia has not been evaluated. Our hypothesis is that individualized fluid optimization may prevent frequency and magnitude of hypotension with spinal anesthesia.

Condition	Intervention
Hypovolemia	Procedure: Stroke volume optimization

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Blood Pressure During Spinal Anesthesia and the Effect of Fluid Optimization

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Blood pressure

Secondary Outcome Measures:

Brain oxygenation

Estimated Enrollment:	32
Study Start Date:	September 2007
Estimated Study Completion Date:	May 2008

Detailed Description:

Hypotension after induction of spinal anaesthesia occurs frequently. However the frequency and magnitude is unpredictable. Evaluations with fixed regimens for fluid optimization as a prevention of hypotension has not been encouraging but an individualized strategy for optimization has not been evaluated in this context. SV maximization has been proposed as a definition of normovolemic status and use of this strategy has improved outcome postoperatively. The purpose of this study is therefore to evaluate the effect of SV maximization with aid of the LiDCO system which is a minimal invasive technique only requiring a venous and arterial line. We thereby attempt to cover the specific individual fluid deficit in one group and compare with a control group with no optimization.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Scheduled knee arthroplastic

Exclusion Criteria:

Weight below 40 kg
Lithium therapy
Type I diabetes or type II requiring insulin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435422

Contacts

Contact: Morten Bundgaard-Nielsen, MD

0045 35 45 09 55

morten.bundgaard-nielsen@rh.dk

Locations

Denmark
Hvidovre University Hospital	Recruiting
Hvidovre, Denmark, 2650
Contact: Morten Bundgaard-Nielsen, MD
Contact: Billy B Kristensen, MD
Principal Investigator: Morten Bundgaard-Nielsen, MD

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator:	Morten Bundgaard-Nielsen, MD	Section of surgical pathophysiology
Principal Investigator:	Morten Bundgaard-Nielsen, MD	unafiliated

More Information

Study ID Numbers:	Spinal and BP
Study First Received:	February 14, 2007
Last Updated:	October 12, 2007
ClinicalTrials.gov Identifier:	NCT00435422
Health Authority:	Denmark: National Board of Health

Study placed in the following topic categories:

Hypovolemia

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 13, 2009