Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
13/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr P Townsend

ORCID ID

Contact details

Anaesthetics
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265006729

Study information

Scientific title

Acronym

Study hypothesis

We intend to carry out a prospective, randomised trial comparing the use of incremental or high dose sevoflurane with O2/N2O for the induction of children under two years of age, to investigate this observed reaction to sevoflurane. We expect to see bradycardias only in the high dose group. Both methods are standard induction techniques.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Anaesthesia in elective surgery

Intervention

With parental consent, all children scheduled to undergo elective surgery who are to receive an inhalational induction will be eligible. Patients will be randomised to receive either incremental or high dose sevoflurane. The rate will be electronically recorded during induction of anaesthesia. Data will be subsequently analysed for alterations of heart rate: severe bradycardia being defined as a 20% reduction in heart rate from the baseline.

Intervention type

Drug

Phase

Not Specified

Drug names

Sevoflurane

Primary outcome measures

Data will be subsequently analysed for alterations of heart rate: severe bradycardia being defined as a 20% reduction in heart rate from the baseline.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2000

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Children under two years of age with parental consent, all children scheduled to undergo elective surgery who are to receive an inhalational induction will be eligible.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2000

Recruitment end date

01/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Anaesthetics
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

University Hospital Birmingham NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes