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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | Perioperative fluid management based on body weight |
|
| II | Active Comparator | Perioperative fluid management based on Lean Body Mass (LBM) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid administration | Procedure | Preoperative: bolus of 10 ml/kg body weight. During operation: 5 ml/kg body weight/hr. Postoperative: 3 ml/kg body weight/hr |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change between preoperative and postoperative plasma sodium concentration | 24 hrs |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johan Ullman, MD., PhD. | Contact | +46 8 51 77 00 00 | johan.ullman@karolinska.se | |
| Vibeke Moen, MD | Contact | +4648081200 | vibekem@ltkalmar.se |
| Name | Affiliation | Role |
|---|---|---|
| Johan Ullman, MD., PhD. | Dept of Anesthesia and Intensive Care, Karolinska University Hospital, Stockholm, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia and Intensive Care, Karolinska University Hospital Huddinge | Recruiting | Stockholm | Stockholm County | 14186 | Sweden |
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| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| D014883 | Water-Electrolyte Imbalance |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D055103 | Hypodermoclysis |
| ID | Term |
|---|---|
| D055104 | Infusions, Subcutaneous |
| D007263 | Infusions, Parenteral |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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| Perioperative fluid management based on Lean Body Mass | Procedure | Preoperative: bolus of 12 ml/kg LBM. During operation: 6 ml/kg LBM/hr. Postoperative: 3.5 ml/kg LBM/hr |
|
|
| Dept of Anaesthesia and Intensive Care, Kalmar County Hospital | Not yet recruiting | Kalmar | 39185 | Sweden |
|
| Department of Anaesthesia and Operation | Recruiting | Linköping | 58185 | Sweden |
|
| Dept. of Anesthesiology and Intensive Care, Karolinska University Hospital, Solna | Recruiting | Stockholm | 171 76 | Sweden |
|
| Dept of Anaesthesia and Intensive Care, Uppsala University Hospital | Terminated | Uppsala | 75185 | Sweden |
| D013812 |
| Therapeutics |
| D005440 | Fluid Therapy |