CompletedPhase 4ACTRN12610000252011

Randomised Control Trial: Intravenous versus inhalational induction in infants and children (0-8 years) with a high risk for respiratory complications undergoing minor elective surgical procedures with laryngeal mask airways


Sponsor

Britta Regli-von Ungern

Enrollment

300 participants

Start Date

Aug 6, 2010

Study Type

Interventional

Conditions

Summary

Despite the development of anaesthesia management guidelines, perioperative respiratory adverse events (PRAE) remain a major cause of morbidity and mortality during paediatric anaesthesia, causing more than three quarters of critical incidents and nearly one third of all perioperative cardiac arrests. In a previous cohort study in over 9000 children, we identified several risk factors (current or recent upper respiratory tract infection, wheezing more than 3 times in the last 12 months, eczema, nocturnal dry cough, a family history of asthma, eczema, rhinitis or passive smoking) which can help in every day clinical practice to identify the children at a particularily high risk for PRAE. A recent large cohort study conducted by the anaesthetic department of Princess Margaret Hospital, “Risk assessment for respiratory complications in paediatric anaesthesia” by von Ungern-Sternberg, Habre, Boda, Rebmann, Johnson, Sly, and Chambers, identified the type of anaesthesia impacted on the risk of RAE occurring. In this observational study, intravenous (i.v.) induction with propofol was associated with a significantly lower incidence of RAE compared with inhalational induction with sevoflurane, particularly with regard to the occurrence of laryngospasm (RR 3.2[2.6-4] p less than 0.0001). However, worldwide inhalational induction of anaesthesia is the most common way of anaesthesia induction in children because it avoids a needle prick in the awake child. The aim of this study is to randomise 300 infants and children (0-8 years) with a high risk for respiratory complications, who are undergoing minor elective surgery, to receive either an i.v. induction with propofol or an inhalational induction with sevoflurane. All patients will be monitored for the occurrence of RAE in the perioperative period. We hypothesize that patients receiving i.v. propofol will demonstrate less respiratory complications (laryngospasm, bronchospasm, desaturation less than 95%, airway obstruction, severe coughing and/or postoperative stridor compared with patients receiving sevoflurane (22% as compared to 38%). These values are based on our previous large cohort study.


Eligibility

Sex: Both males and femalesMax Age: 8 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two ways of putting children aged 0 to 8 to sleep for minor surgery: intravenous (through a needle) versus inhaled anesthetic gas. It focuses on children who have a higher risk of breathing problems during anesthesia, such as those with recent colds, eczema, or a family history of asthma.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

intravenous induction of anaesthesia with intravenous propofol (as per attending anaesthetist 2-5 mg/kg). The induction of anaesthesia is a very brief one/off intervention (approx. 2 min).

intravenous induction of anaesthesia with intravenous propofol (as per attending anaesthetist 2-5 mg/kg). The induction of anaesthesia is a very brief one/off intervention (approx. 2 min).


Locations(1)

Princess Margaret Hospital - Subiaco

WA, Australia

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ACTRN12610000252011