The effects of Sterofundin versus Ringer's Lactate on Acid-base balance and electrolyte status in paediatric patients undergoing major urogenital surgery.

Phase 4

Recruiting

• Conditions: 1.to determine any significant differences in acid base balance in paediatric patients undergoing major surgery .; 2.to determine any significant differences in electrolyte balance and haemodynamic stability in paediatric patients undergoing major surgery.; Anaesthesiology - Other anaesthesiology; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12612000107820
• Lead Sponsor: university malaya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

The inclusion criteria for this study required the patients to be of paediatric age group (more than 1 year old to less than 13 years old), to be of ASA physical status I, II or III, undergoing major elective Urogenital surgery (duration of more than 2 hours)

Exclusion Criteria

Patients with renal failure or renal impairment, cardiac or liver failure, anomalies of the heart, hypervolaemic states, severe generalised oedema, electrolyte imbalance, metabolic acidosis and known allergies to sterofundin .

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pH via arterial blood gases measurements.<br>Arterial blood gases are taken at start (baseline) then hourly during the surgery and the last arterial blood gas is taken one hour postoperatively.<br>From the arterial blood gas results, pH, PCO2, PO2, bicarbonate, base excess, sodium, potassium, chloride, glucose and haemoglobin levels were recorded. This will assess whether the ph is decreased or increased from patient's baseline.[A sample size calculation based on the expected 0.05 difference in pH in the mean population, and alpha of 0.05 and beta of 80%, leads to a minimum sample size of 15 in each side.<br>Arterial blood gases are taken at start (baseline) then hourly during the surgery and the last arterial blood gas are taken one hour postoperatively.<br>From the arterial blood gas results, pH, PCO2, PO2, bicarbonate, base excess, sodium, potassium, chloride, glucose and haemoglobin levels were recorded.]

Secondary Outcome Measures

Name	Time	Method
chloride.<br>Arterial blood gases are taken at start (baseline) then hourly during the surgery and the last arterial blood gas is taken one hour postoperatively.<br>From the arterial blood gas results, pH, PCO2, PO2, bicarbonate, base excess, sodium, potassium, chloride, glucose and haemoglobin levels were recorded.[A sample size calculation based on the expected 5 mmol difference in chloride in the mean population, and alpha of 0.05 and beta of 80%, leads to a minimum sample size of 25 in each side]