Sevoflurane-remifentanyl versus propofol-remifentanyl in surgery exceeding 4 hours
| ISRCTN | ISRCTN25537214 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25537214 |
| Secondary identifying numbers | 02/138 |
- Submission date
- 08/09/2005
- Registration date
- 11/11/2005
- Last edited
- 04/08/2010
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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 Basil Matta
Scientific
Scientific
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
Study information
| Study design | Randomised active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | SEVO |
| Study objectives | No difference between the two types of anaesthetics in patient haemodynamic or wake up characteristics. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Prolonged surgery |
| Intervention | Please note that as of 04/08/10 the status of this trial has been updated to "Stopped". The study was closed on 16/01/09 due to difficulties in patient recruitment. The study did not reach sufficient power for trialists to reach a conclusion based on statistical significance. The main findings were that in the limited number of subjects studied, there no significant differences between the groups in either the primary or secondary objectives. However, it was evident that both techniques can be used effectively for these types of operations. Randomised into receiving one of two types of anaesthesia. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Sevoflurane, remifentanyl, propofol |
| Primary outcome measure | Haemodynamic stability |
| Secondary outcome measures | 1. Nausea 2. Vomiting 3. Wake up time |
| Overall study start date | 12/06/2002 |
| Completion date | 01/01/2008 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | Patients undergoing surgery over 4 hours. |
| Key exclusion criteria | 1. Allergy to sevoflurane or remifentanyl 2. Patient refusal 3. Morbidly obese 4. American Society of Anesthesiologists (ASA) 3 or higher |
| Date of first enrolment | 12/06/2002 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Addenbrooke's Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Claudia Rizzini
R&D Department
Addenbrooke's Hospital
Cambridge
CB2 2QQ
England
United Kingdom
"ROR" |
https://ror.org/055vbxf86 |
|---|
Funders
Funder type
Industry
Abbott Laboratories (UK) - Unrestricted educational grant
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 |
