Fluid Infusion During Breast Surgery
Phase 4 Study of Fluid Infusion During Breast Surgery.
1 other identifier
interventional
32
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2007
CompletedFirst Posted
Study publicly available on registry
February 6, 2007
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedMarch 3, 2009
February 1, 2009
5 months
February 5, 2007
February 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To investigate orthostatic function, measured by Finapress
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej
Copenhagen, Region Sjælland, 2200, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Henrik Kehlet, M.D. Ph.d.
dept of surgical patophysiology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 5, 2007
First Posted
February 6, 2007
Study Start
April 1, 2009
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
March 3, 2009
Record last verified: 2009-02