Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
02/138
Study information
Scientific title
Acronym
SEVO
Study hypothesis
No difference between the two types of anaesthetics in patient haemodynamic or wake up characteristics.
Ethics approval
Not provided at time of registration
Study design
Randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Sevoflurane, remifentanyl, propofol
Primary outcome measures
Haemodynamic stability
Secondary outcome measures
1. Nausea
2. Vomiting
3. Wake up time
Overall trial start date
12/06/2002
Overall trial end date
01/01/2008
Reason abandoned
Participant recruitment issue
Eligibility
Participant inclusion criteria
Patients undergoing surgery over 4 hours.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Allergy to sevoflurane or remifentanyl
2. Patient refusal
3. Morbidly obese
4. American Society of Anesthesiologists (ASA) 3 or higher
Recruitment start date
12/06/2002
Recruitment end date
01/01/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
Funders
Funder type
Industry
Funder name
Abbott Laboratories (UK) - Unrestricted educational grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary