Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
20/08/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr MRJ Sury

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0012134104

Study information

Scientific title

Acronym

Study hypothesis

Which noise causes reliable sub-cortical arousal in infants during anaesthesia?

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

Hospitals

Trial type

Other

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Sub-cortical arousal

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2005

Overall trial end date

31/08/2007

Reason abandoned

Objectives no longer viable

Eligibility

Participant inclusion criteria

Infants undergoing anaesthesia

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/02/2005

Recruitment end date

31/08/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Anaesthetics
London
WC1N 3JH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

Great Ormond Street Hospital for Children NHS Trust/Institute of Child Health (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