Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
11/10/2011
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 A Eissa

ORCID ID

Contact details

Anaesthetics
Sheffield Children's NHS Trust
Western Bank
Sheffield
S10 2TH
United Kingdom
+44 (0)114 2717522

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0220124701

Study information

Scientific title

Acronym

Study hypothesis

Can we successfully perform endotracheal intubation in children using a remifentanil technique and obtain as good conditions as with suxamethonium but without the side effects?

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

Not Specified

Patient information sheet

Condition

Surgery: Anaesthesia

Intervention

On arrival in the anaesthetic room, standard monitoring will be applied; peripheral pulse oximeter (SpoO2), electrocardiogram (ECG), non invasive blood pressure (NIBP), and intravenous access sited.

The anaesthetist will open an envelope randomly allocating the patient into one of two groups: Group S to receive Suxamethonium or Group R to receive Remifentanil and will then draw up the appropriate drug for intubation. The child will then be anaesthetised using propofol 3 mg/kg administered over 30 seconds, followed by either Suxamethonium or Remifentanil. A second clinical investigator, unaware of the drug allocation, will enter the anaesthetic room once the patient is asleep and will perform the intubation. Maintenance of anaesthesia will be provided by oxygen/nitrous oxide/Isoflurane gases and hand ventilation at a rate of 6 breaths per minute, monitoring the expired carbon dioxide with capnography. Anaesthesia and surgery will then proceed as normal and on completion the patient will be woken and recovered in the usual manner.

Intervention type

Drug

Phase

Not Specified

Drug names

remifentanil, suxamethonium

Primary outcome measures

1. Heart rate, blood pressure, oxygen saturation and end tidal carbon dioxide as part of normal anaesthesia. Apnoea time from end of propofol injection to first recognisable breath.
Intubation conditions
2. Intubating condition scores:
Jaw relaxation score: 1 - Relaxed, 2 - Raised Tone, 3 - Rigid
Laryngoscopy score: 1 - Easy, 2 - Difficult, 3 - Impossible
Vocal cords score: 1 - Open, 2 - Moving, 3 - Closed
Coughing score: 1 - None, 2 - Slight, 3 - Severe
Limb movement score: 1 - None, 2 - Slight, 3 - Severe
All score 1 = excellent, some score 2 = good, any score 3 = poor.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

31/01/2003

Overall trial end date

31/07/2003

Reason abandoned

Eligibility

Participant inclusion criteria

30 patients will be required in each group in the study.
To our knowledge there are no studies of direct comparison between techniques using either suxamethonium or remifentanil for intubation in the paediatric population. We have found no studies assessing intubating condition, cardiovascular response and apnoea time in children at a lower dose of remifentanil of 1.25 mcg/kg. This would be possible in children presenting for surgery, who would already require general anaesthesia and intubation and in whom paralysis is not a requirement for surgery itself.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

31/01/2003

Recruitment end date

31/07/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Anaesthetics, Sheffield Children's NHS Trust
Sheffield
S10 2TH
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

Government

Funder name

Sheffield Children's NHS Foundation Trust

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

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17223805

Publication citations

  1. Results

    Morgan JM, Barker I, Peacock JE, Eissa A, A comparison of intubating conditions in children following induction of anaesthesia with propofol and suxamethonium or propofol and remifentanil., Anaesthesia, 2007, 62, 2, 135-139, doi: 10.1111/j.1365-2044.2006.04903.x.

Additional files

Editorial Notes