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The proposed study will focus on anesthesia and anesthesia-induced hypotension as a possible cause for postoperative fluid retention and hyponatremia, and investigate gender differences in this response.
Full description
30 healthy women and 30 healthy men, who are scheduled for surgery of the middle ear or parotic gland are included in the study. Within each gender group, the subjects are randomized to receive perioperative intravenous fluid regimes either based on body weight or lean body mass (LBM). The surgery lasts for at least 3 hours, the intervention period (fluid administration according to protocol) will last 10-12 hours, the study period will be 20-24 hours. Blood samples for analysis of plasma sodium, potassium, glucose and osmolality are collected preoperatively and the following morning together with analysis of urine produced during the study period.
Enrollment
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Inclusion criteria
Exclusion criteria
BMI less than 18
BMI greater than 33
Diabetes mellitus requiring medication
Treatment with diuretics
ACE-inhibitors
Angiotensin II antagonists
Cortisone
Lithium
Diseases of the kidney
Females:
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
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Central trial contact
Vibeke Moen, MD; Johan Ullman, MD., PhD.
Data sourced from clinicaltrials.gov
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