Postoperative Hyponatremia - Are There Gender Differences?

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00636857

Enrollment

Registered

2008-03-17

Start date

2008-03-31

Completion date

2013-12-31

Last updated

2013-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia

Keywords

Water-Electrolyte Imbalance

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.

Interventions

PROCEDUREFluid administration

Preoperative: bolus of 10 ml/kg body weight. During operation: 5 ml/kg body weight/hr. Postoperative: 3 ml/kg body weight/hr

PROCEDUREPerioperative fluid management based on Lean Body Mass

Preoperative: bolus of 12 ml/kg LBM. During operation: 6 ml/kg LBM/hr. Postoperative: 3.5 ml/kg LBM/hr

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change between preoperative and postoperative plasma sodium concentration	24 hrs

Countries

Sweden

Contacts

Primary ContactJohan Ullman, MD., PhD.

johan.ullman@karolinska.se+46 8 51 77 00 00

Backup ContactVibeke Moen, MD

vibekem@ltkalmar.se+4648081200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026