Condition category
Surgery
Date applied
08/09/2005
Date assigned
11/11/2005
Last edited
04/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Basil Matta

ORCID ID

Contact details

Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

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

Sponsor information

Organisation

Addenbrooke's Hospital (UK)

Sponsor details

Claudia Rizzini
R&D Department
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes