Fluid Infusion During Breast Surgery
Recruitment status was Not yet recruiting
The investigators want to investigate the effects of two different kinds of fluid infusions given during varicose vein surgery. Both types of fluid are regularly given during surgery, and the investigators want to compare their respective effects on balance, nausea/vomiting and orthostatic function after surgery.
The investigators' hypothesis is that using a colloid solution will improve orthostatic function, balance, nausea/vomiting and reduce hospital stay.
Drug: Hydroxyethylstarch 130/0,4
Drug: Lactated Ringer's solution
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Phase 4 Study of Fluid Infusion During Breast Surgery.|
- To investigate orthostatic function, measured by Finapress
- To investigate the occurrence of postsurgery nausea/vomiting.
- To investigate the amount of time until discharge criteria from the Postanaesthetic Care Unit have been achieved.
- To investigate balance function, measured by BalanceMaster
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||September 2009|
|Estimated Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
The optimal amount and type of fluid given during surgery has not been defined. It has been agreed that hypovolemia must be avoided, but at the same time it has been agreed that fluid excess is harmful for organ function.When distributing fluids it is usually either crystalloids og colloids which are given. The effects of the two types of fluid have not been compared. Our hypothesis is that using a colloid (HES 130/0,4) will improve orthostatic function, nausea/vomiting and shorten hospital stay, compared to using a crystalloid (Lactated Ringer's solution).The amount of fluid the patient receives, will be individually tailored by monitoring SV using esophageal Doppler technique during surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431743
|Contact: Morten Bundgaard-Nielsen, M.D.||0045 firstname.lastname@example.org|
|Contact: Henrik Kehlet, M.D. Ph.d||0045 email@example.com|
|Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej||Not yet recruiting|
|Copenhagen, Seeland, Denmark, 2200|
|Principal Investigator: Morten Bundgaard-Nielsen, M.D.|
|Sub-Investigator: Christoffer C Jørgensen, M.S.|
|Study Director:||Henrik Kehlet, M.D. Ph.d.||dept of surgical patophysiology|