Comparison of intubating conditions in children after induction of anaesthesia following propofol and suxamethonium with propofol and remifentanil.

ISRCTN	ISRCTN81476069
DOI	https://doi.org/10.1186/ISRCTN81476069
Protocol serial number	N0220124701
Sponsor	Department of Health
Funder	Sheffield Children's NHS Foundation Trust

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 11/10/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A Eissa
Scientific

Anaesthetics, Sheffield Children's NHS Trust
Western Bank
Sheffield
S10 2TH
United Kingdom

Phone	+44 (0)114 2717522

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	remifentanil, suxamethonium
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/07/2003

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Not Specified
Target sample size at registration	60
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	31/01/2003
Date of final enrolment	31/07/2003

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Anaesthetics, Sheffield Children's NHS Trust

Sheffield
S10 2TH
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2007		Yes	No