ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610000252011

Ethics application status

Approved

Date submitted

12/03/2010

Date registered

24/03/2010

Date last updated

12/01/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Respiratory complications following inhalational or intravenous induction of anaesthesia

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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).

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

inhalational induction of anaesthesia
The induction of anaesthesia is a very brief one/off intervention (approx. 2 min).

Control group

Active

Outcomes

Primary outcome [1]

Incidence of respiratory complications in the perioperative period
Presence of perioperative respiratory complication as defined by one or more of the following:
Bronchospasm, laryngospasm, severe coughing, desaturation < 95%, airway obstruction and/or stridor.
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.

Timepoint [1]

intraoperatively until discharge from the recovery area

Secondary outcome [1]

occurrence and frequency of the individual respiratory complications in both intra-operatively and in the recovery area.
The outcome will be assessed by clinical monitoring

Timepoint [1]

intraoperatively until discharge from the recovery area

Eligibility

Key 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.

Minimum age

No limit

Maximum age

8 Years

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

All patients will be recruited at the pre-anaesthetic visit. Only patients who meet the inclusion criteria for the study will be enrolled and only after informed consent is given voluntarily by the parent/guardian. The patients will be randomised by computer generated block randomisation. The participant will be assigned the next available Participant Number.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The patients will be randomised by computer generated block randomisation. Following written informed consent, the participant will be assigned the next available Participant Number. The Participant Number will correspond to a numbered randomisation envelope. The randomisation is concealed in the closed envelope and will only be opened by the anaesthetist in charge of the patient at induction of anaesthesia. The participant number will be used to identify the patient for the duration of the study.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/05/2010

Actual

6/08/2010

Date of last participant enrolment

Anticipated

Actual

20/11/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

300

Accrual to date

Final

300

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Princess Margaret Hospital - Subiaco

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Princess Margaret Hospital for Children

Address [1]

Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Princess Margaret Hospital Foundation

Address [2]

Princess Margaret Hospital Foundation
Level 1,
68 Hay Street
Subiaco
WA 6008
Australia

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

NHMRC

Address [3]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [3]

Australia

Primary sponsor type

Individual

Name

Britta Regli-von Ungern

Address

Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Neil Chambers

Address [1]

Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Margaret Hospital for Children Ethics Committee

Ethics committee address [1]

Princess Margaret Hospital for Children Ethics Committee
Level 1
Children’s Clinical Research Facility
Princess Margaret Hospital
Roberts Road
SUBIACO WA 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/03/2010

Approval date [1]

20/05/2010

Ethics approval number [1]

1787/EP

Summary

Brief 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.

Trial website

Trial related presentations / publications

Papers are currently being drafted. Once published this section will be updated.

Public notes

Contacts

Principal investigator

Name

Prof Britta Regli-von Ungern

Address

Princess Margaret Hospital for Children
Department of Anaesthesia and Pain Management
Roberts Road
SUBIACO,
WA 6008

Country

Australia

Phone

+61893408109

Fax

britta.regli-vonungern@health.wa.gov.au

Contact person for public queries

Name

Britta Regli-von Ungern

Address

Princess Margaret Hospital for Children
Department of Anaesthesia and Pain Management
Roberts Road
SUBIACO,
WA 6008

Country

Australia

Phone

+61893408109

Fax

britta.regli-vonungern@health.wa.gov.au

Contact person for scientific queries

Name

Britta Regli-von Ungern

Address

Princess Margaret Hospital for Children
Department of Anaesthesia and Pain Management
Roberts Road
SUBIACO,
WA 6008

Country

Australia

Phone

+61893408109

Fax

britta.regli-vonungern@health.wa.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Inhalational versus Intravenous Induction of Anesthesia in Children with a High Risk of Perioperative Respiratory Adverse Events: A Randomized Controlled Trial.	2018	https://dx.doi.org/10.1097/ALN.0000000000002152

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically