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 |
| Secondary identifying numbers | N0220124701 |
- 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
Scientific
Anaesthetics, Sheffield Children's NHS Trust
Western Bank
Sheffield
S10 2TH
United Kingdom
| Phone | +44 (0)114 2717522 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | remifentanil, suxamethonium |
| Primary outcome measure | 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 study start date | 31/01/2003 |
| Completion date | 31/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Anaesthetics, Sheffield Children's NHS Trust
Sheffield
S10 2TH
United Kingdom
S10 2TH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Sheffield Children's NHS Foundation Trust
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
