Enhanced Recovery After Cardiac Surgery
NCT03859102 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2019-09-27
Summary
Enhanced Recovery Protocols (ERPs or bundles) have been established in many surgical specialties (such as colon cancer and orthopaedic joint surgeries) for several years in hospitals worldwide. The principles of Enhanced Recovery Protocols are those of early mobilization and restoration of normal function as soon as possible after surgery. These principles are achieved by use of alternate pain control regimens and removing invasive lines and drains as soon as possible. The benefits of ERPs are improved patient experience, earlier return to normal function and reduced length of stay. Enhanced recovery protocols for cardiac surgery have been published by the Enhanced Recovery After Cardiac Surgery Society.
The current study will investigate whether it is possible to utilise ERP bundles in the population of cardiac surgery patients at James Cook Hospital, with a view to rolling out a full ERP service. Secondary study outcomes will be patient-centred, including; pain scores, nausea and vomiting rates and time taken to return to normal function.
Conditions
- Cardiac Surgery
- Coronary Artery Disease
- Aortic Valve Disease
- Mitral Valve Disease
- Tricuspid Valve Disease
- Aortic Root Dilatation
Interventions
- DIETARY_SUPPLEMENT
-
Pre-operative Carbohydrate PreLoad drink
Pre-operative Carbohydrate PreLoad drink, 1 sachet given the night before surgery. One sachet given 2-4hours before surgery.
- DRUG
-
Oral Gabapentin pre-op
One dose of Gabapentin pre-operatively, 300mg orally.
- DRUG
-
Oral Lansoprazole pre-op
One dose of Lansoprazole pre-operatively, 30mg orally.
- DRUG
-
Intravenous Paracetamol intra-operatively
One dose of Paracetamol intra-operatively, 1gram intravenous infusion.
- DRUG
-
Intravenous Dexamethasone intra-operatively
One dose of Dexamethasone intra-operatively as an anti-emetic, 8mg intravenous.
- DRUG
-
Intravenous Ondansetron intra-operatively
One dose of Ondansetron intra-operatively as an anti-emetic, 4mg intravenous
- DRUG
-
Infiltration of surgical wounds with local anaesthetic
Infiltration of surgical wounds with local anaesthetic at the end of surgery, Bupivacaine 1-2mg/kg.
- DRUG
-
Intravenous Magnesium intra-operatively
One infusion of intravenous Magnesium Sulphate intra-operatively as an analgesic, 50mg/kg given over 30minutes.
- DRUG
-
Post-operative Gabapentin analgesia
Post-operative oral Gabapentin 300mg, three times daily as an analgesic.
- DRUG
-
Post-operative oral Paracetamol analgesia
Post-operative Paracetamol as an analgesic. Initially intravenously, then orally. One gram four times daily.
- DRUG
-
Post-operative Ondansetron anti-emesis
Intravenous Ondansetron administered post-operatively as prophylactic anti-emesis. 4mg three times daily, for 24 hours. Then as required.
- PROCEDURE
-
Early extubation
Removal of the endotracheal tube in the Intensive Care Unit as soon as is safe.
- PROCEDURE
-
Early mobilisation/physiotherapy
Mobilisation (active and passive limb movements, deep breathing) with the assistance of nurse/physiotherapist to occur as soon as possible post-operatively.
- OTHER
-
Encourage early oral food intake
Patients will be encouraged to start eating as soon as possible post-operatively
Sponsors & Collaborators
-
Medela AG
collaborator INDUSTRY -
James Cook University Hospital
lead OTHER
Principal Investigators
-
Jim C Coates, MBBS · James Cook University Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-17
- Primary Completion
- 2019-10-01
- Completion
- 2019-11-29
Countries
- United Kingdom
Study Locations
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