Arousal of infants to noise during recovery from anaesthesia

ISRCTN	ISRCTN36739423
DOI	https://doi.org/10.1186/ISRCTN36739423
Protocol serial number	N0012134104
Sponsor	Department of Health
Funder	Great Ormond Street Hospital for Children NHS Trust/Institute of Child Health (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 MRJ Sury
Scientific

Anaesthetics
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Which noise causes reliable sub-cortical arousal in infants during anaesthesia?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Anaesthesia
Intervention	Randomised controlled trial. Random allocation to: 1. Noise types 2. Control 20/08/2012: Please note that as of 21/02/2008 this trial was stopped.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Sub-cortical arousal
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/08/2007
Reason abandoned (if study stopped)	Objectives no longer viable

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	Infants undergoing anaesthesia
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/02/2005
Date of final enrolment	31/08/2007

Anaesthetics

London
WC1N 3JH
United Kingdom

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