Condition category
Surgery
Date applied
16/09/2004
Date assigned
05/01/2005
Last edited
26/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Arno Nierich

ORCID ID

Contact details

PO Box 10500
Zwolle
8000 GM
Netherlands

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

Sponsor information

Organisation

Isala Clinics, Zwolle (Isala Klinieken) (Netherlands)

Sponsor details

Health Care Improvement Project
PO Box 10500
Zwolle
8000 GM
Netherlands

Sponsor type

Not defined

Website

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

Publication citations

Additional files

Editorial Notes