Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
13/03/2014
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 D Green

ORCID ID

Contact details

Anaesthetics
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265006248

Study information

Scientific title

Acronym

Study hypothesis

The aim of this study is to compare the efficacy of intrathecal morphine and intravenous remifentanil against a standard analgesic technique in patients undergoing elective myocardial revascularisation. There are two main questions that it aims to answer:
1. Does this method provide a smooth, reliable, and pain-free recovery after surgery?
2. Is there any difference in pain control, recovery characteristics (e.g. time to resumption of spontaneous respiration, time to reach extubation criteria), or side effect profile?

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Signs and Symptoms: Post operative pain

Intervention

Each volunteer will be randomly allocated (using random number tables) to one of two groups:
1. Intrathecal morphine/Remifentanil group
2. Fentanyl/Alfentanil (control) group

After transfer to the ITU the volunteer will remain sedated until they are haemodynamically stable, have a body temperature above 35 degrees Celsius, and are not excessively bleeding. At this point the sedative agent will be stopped and the volunteer will be extubated after specific extubation criteria have been met.

Data will be collected for the pre-, intra-, and post-operative periods.

One of the investigators will remain with the volunteer from the time of ITU admission to the end of the study period. He/she will be responsible for all data collection and will oversee the analgesic management.

The volunteer may request to withdraw from the study at any time. The investigator will withdraw the volunteer from the study if:
1. A critical incident occurs
2. There are peri-operative complications e.g. myocardial dysfunction requiring inotropic support
3. There is excessive post-operative bleeding

Intervention type

Drug

Phase

Not Specified

Drug names

intrathecal morphine, intravenous remifentanil

Primary outcome measures

To compare the efficacy of intrathecal morphine and intravenous remifentanil against a standard analgesic technique in patients undergoing elective myocardial revascularisation.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2004

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with preserved myocardial function undergoing elective myocardial revascularisation having given written informed consent.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2004

Recruitment end date

01/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Anaesthetics
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

University Hospital Birmingham NHS Trust (UK)

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