A comparison of inhalational induction of anaesthesia between incremental doses of sevoflurane and high dose sevoflurane in children under 2 years of age

ISRCTN	ISRCTN05541118
DOI	https://doi.org/10.1186/ISRCTN05541118
Protocol serial number	N0265006729
Sponsor	Department of Health
Funder	University Hospital Birmingham NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr P Townsend
Scientific

Anaesthetics
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Sevoflurane
Primary outcome measure(s)	Data will be subsequently analysed for alterations of heart rate: severe bradycardia being defined as a 20% reduction in heart rate from the baseline.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2007

Participant type(s)	Patient
Age group	Child
Upper age limit	2 Years
Sex	All
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2000
Date of final enrolment	01/01/2007

Anaesthetics

Birmingham
B15 2TH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan