Fluid Infusion During Breast Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase 4 Study of Fluid Infusion During Breast Surgery.

Conditions
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Breast Surgery

Intervention / Treatment
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* Drug: Hydroxyethylstarch 130/0,4
* Drug: Lactated Ringer's solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients having performed elective breast surgery. Age between 18 and 70 years Patients who have given written consent to participate in the project after haven completely understood the contents and limitations of the protocol. Exclusion Criteria: Patients who do not understand or speak Danish Patients who have not signed the informed consent or the written authority pre-medication, except 1g paracetamol ASA > II Pregnant or breastfeeding Known to have Renal disease Known to have Psychiatric disorder (not considering the use of SSRI antidepressive) Need for crash induction or prone position. Oesophageal varicoses Necrosis or cancer in: Mouth, Pharynx, Larynx or Oesophagus Coarctation or aneurism in the proximal Aorta Severe bleeding disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Hydroxyethylstarch 130/0,4|nan|
|Drug: Lactated Ringer's solution|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate orthostatic function, measured by Finapress |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluid Therapy, Crystalloid, Colloid, Perioperative, Optimization, Goal-directed Therapy