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

Phase 4

Completed

• Conditions: Respiratory complications following inhalational or intravenous induction of anaesthesia; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12610000252011
• Lead Sponsor: Britta Regli-von Ungern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Children, aged 0 to 8 years, male or female undergoing elective minor surgery with 2 or more risk factors:8 1. Cold or flu currently or in the last 2 weeks 2. Eczema at present or in the past 3. Wheezing in the last 12 months 4. Asthma in the past (if wheezing in the last 12 months is negative) 5. Dry night cough 6. Bronchial hyperreactivity at exercise 7. Family history of asthma (mother, father and/or siblings) 8. Family history of eczema (mother, father and/or siblings) 9. Family history of hayfever (mother, father and/or siblings) 10. Passive smoking (mother, father, caregiver) These patients are undergoing the following types of procedures: magnetic resonance imaging (MRI), eye surgery, endoscopy, minor orthopaedic, grommets, minor general surgery and minor plastics procedures.

Exclusion Criteria

Known cardiac disease, airway or thoracic malformations, syndrome, neurological disorder, need for premedication, contraindication for i.v. or inhalational induction and/or for laryngeal mask airway (LMA) use as assessed by an anaesthetist independent of the study team. Any surgery involving the upper airway, chest or abdomen

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of respiratory complications in the perioperative period<br>Presence of perioperative respiratory complication as defined by one or more of the following:<br>Bronchospasm, laryngospasm, severe coughing, desaturation < 95%, airway obstruction and/or stridor.<br>The presence/absence of respiratory complications will be recorded during the time of anaesthesia and the time spent in recovery. The overall presence of respiratory complications will be taken for the analysis.[intraoperatively until discharge from the recovery area]

Secondary Outcome Measures

Name	Time	Method
occurrence and frequency of the individual respiratory complications in both intra-operatively and in the recovery area.<br>The outcome will be assessed by clinical monitoring[intraoperatively until discharge from the recovery area]