Randomised controlled, double blinded single centre trial to assess the effects of peri-operative dopexamine on morbidity after major abdominal surgery in patients with low anaerobic threshold

Completed

• Conditions: Major Abdominal Surgery; Surgery

• Registration Number: ISRCTN33549216
• Lead Sponsor: York Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Patients undergoing scheduled resection for carcinoma of the colon, rectum, bladder, pancreas, stomach or kidney, who, after routine Cardiopulmonary exercise (CPX) testing at the Pre-assessment Clinic, have been found to have an Anaerobic Threshold (AT) less than or equal to 11.0 ml/min/m2 as measured by the V-slope method 15, or with an AT of 11.0 -14.0 ml/min/m2 and ischaemic changes on Electrocardiogram (ECG) monitoring during testing or with a significant history of ischaemic heart disease (New York Heart Association [NYHA] classification III and IV).

Exclusion Criteria

1. Less than 60 years of age unless they have significant co-morbidities (American Society of Anaesthesiologists (ASA) score three or greater)
2. Having emergency or vascular procedures
3. ASA grade five
4. Refuse or are unable to give informed consent
5. Hypertrophic Obstructive Cardiomyopathy, aortic stenosis, phaeochromocytoma, a low platelet count, or have used a monoamine oxidase inhibitor within the last 14 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Morbidity at five, ten, and 15 days using the Post-Operative Morbidity Score (POMS) score.

Secondary Outcome Measures

Name	Time	Method
1. Length of stay in hospital after surgery<br>2. Recovery parameters (drinking, eating, mobilising)<br>3. Incidence of post-operative complications<br>4. Peri-operative haemodynamic variables (heart rate, blood pressure, Central Venous Pressure [CVP])<br>5. Physiologic and Operative Severity Score for the enUmeration of Mortality and morbidity (POSSUM) score for surgical risk assessment<br>6. Oxygen delivery