A comparison of inhalational induction of anaesthesia between incremental doses of sevoflurane and high dose sevoflurane in children under 2 years of age
| ISRCTN | ISRCTN05541118 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05541118 |
| Secondary identifying numbers | N0265006729 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 13/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Contact information
Dr P Townsend
Scientific
Scientific
Anaesthetics
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | We intend to carry out a prospective, randomised trial comparing the use of incremental or high dose sevoflurane with O2/N2O for the induction of children under two years of age, to investigate this observed reaction to sevoflurane. We expect to see bradycardias only in the high dose group. Both methods are standard induction techniques. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Anaesthesia in elective surgery |
| Intervention | With parental consent, all children scheduled to undergo elective surgery who are to receive an inhalational induction will be eligible. Patients will be randomised to receive either incremental or high dose sevoflurane. The rate will be electronically recorded during induction of anaesthesia. Data will be subsequently analysed for alterations of heart rate: severe bradycardia being defined as a 20% reduction in heart rate from the baseline. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sevoflurane |
| Primary outcome measure | Data will be subsequently analysed for alterations of heart rate: severe bradycardia being defined as a 20% reduction in heart rate from the baseline. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2000 |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 2 Years |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Children under two years of age with parental consent, all children scheduled to undergo elective surgery who are to receive an inhalational induction will be eligible. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Anaesthetics
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
University Hospital Birmingham NHS Trust (UK)
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 |
