Fluid Infusion During Breast Surgery

Breast Surgery Clinical Trial

Official title:

Phase 4 Study of Fluid Infusion During Breast Surgery.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00431743
• Other study ID #: Mastectomy opti.
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 5, 2007
• Last updated: February 27, 2009
• Start date: April 2009
• Est. completion date: September 2009

Study information

• Verified date: February 2009
• Source: Rigshospitalet, Denmark
• Contact: Morten Bundgaard-Nielsen, M.D.
• Phone: 0045 35452674
• Email: morten.bundgaard-nielsen[@]rh.hosp.dk
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Surgery

Intervention

Drug:
• Hydroxyethylstarch 130/0,4

• Lactated Ringer's solution

Locations

Country	Name	City	State
Denmark	Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej	Copenhagen	Seeland

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate orthostatic function, measured by Finapress
Secondary	To investigate the occurrence of postsurgery nausea/vomiting.
Secondary	To investigate the amount of time until discharge criteria from the Postanaesthetic Care Unit have been achieved.
Secondary	To investigate balance function, measured by BalanceMaster