Sevoflurane-remifentanyl versus propofol-remifentanyl in surgery exceeding 4 hours

ISRCTN	ISRCTN25537214
DOI	https://doi.org/10.1186/ISRCTN25537214
Protocol serial number	02/138
Sponsor	Addenbrooke's Hospital (UK)
Funder	Abbott Laboratories (UK) - Unrestricted educational grant

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

Dr Basil Matta
Scientific

Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Primary study design	Interventional
Study design	Randomised active controlled parallel group trial
Secondary study design	Randomised controlled trial
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
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Sevoflurane, remifentanyl, propofol
Primary outcome measure(s)	Haemodynamic stability
Key secondary outcome measure(s)	1. Nausea 2. Vomiting 3. Wake up time
Completion date	01/01/2008
Reason abandoned (if study stopped)	Participant recruitment issue

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Addenbrooke's Hospital

Cambridge
CB2 2QQ
United Kingdom

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