Postoperative Hyponatremia - Are There Gender Differences?

Not Applicable

• Conditions: Hyponatremia
• Interventions: Procedure: Fluid administration; Procedure: Perioperative fluid management based on Lean Body Mass

• Registration Number: NCT00636857
• Lead Sponsor: Karolinska University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-10
• Study First Submitted QC: 2008-03-10
• Study First Posted: 2008-03-17
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-11
• Last Update Posted: 2013-06-12
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA Physical status I-II
• Subjects scheduled for otorinolaryngoiatric surgery in general anesthesia of at least 3 hours duration

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:

  • Pregnancy
  • Menopause
  • Endocrine dysfunction influencing menstruation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	Fluid administration	Perioperative fluid management based on body weight
II	Perioperative fluid management based on Lean Body Mass	Perioperative fluid management based on Lean Body Mass (LBM)

Primary Outcome Measures

Name	Time	Method
Change between preoperative and postoperative plasma sodium concentration	24 hrs

Trial Locations

Locations (5)

Department of Anaesthesia and Operation; 🇸🇪 Linkoping, Sweden

Dept of Anaesthesia and Intensive Care, Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Department of Anesthesia and Intensive Care, Karolinska University Hospital Huddinge; 🇸🇪 Stockholm, Sweden

Dept of Anaesthesia and Intensive Care, Kalmar County Hospital; 🇸🇪 Kalmar, Sweden

Dept. of Anesthesiology and Intensive Care, Karolinska University Hospital, Solna; 🇸🇪 Stockholm, Sweden