Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Opticare I
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cardiac surgery patients
Intervention
Compare the effect of intravenous anaesthesia combined with thoracic epidural anaesthesia (TEA group), with total intravenous anaesthesia (general anesthetic [GA] group) without epidural anesthesia
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2003
Overall trial end date
30/04/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Consecutive patients scheduled for elective cardiac surgery (coronary artery bypass graft [CABG], valve, redo CABG)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/04/2003
Recruitment end date
30/04/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
PO Box 10500
Zwolle
8000 GM
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Isala Clinics, Zwolle (Isala Klinieken) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Het Groene Land-Achmea Insurance (Netherlands)
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