Trial | NCT03859102  Report issue

Title

Enhanced Recovery After Cardiac Surgery
Feasibility of Delivering Enhanced Recovery After Cardiac Surgery

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    80
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.
Why? 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. These protocols have been demonstrated as safe, though have yet to make it into mainstream practice in the UK. The use of ERPs in Cardiac Surgery has the potential to greatly improve the patient journey and hospital efficiency.

What? 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.

Who? All adult patients over the age of 18 years and listed for cardiac surgery will be considered for inclusion in this study.

Where? The study population will be comprised of patients undergoing cardiac surgery at the James Cook University Hospital in Middlesbrough.

How? Study duration will be 6 months, with 80 patients (comprising a control and intervention group)
Study Started
Dec 17
2018
Primary Completion
Oct 01
2019
Anticipated
Study Completion
Nov 29
2019
Anticipated
Last Update
Sep 27
2019

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

ERAS Control/non-ERAS group No Intervention

Standard usual care after cardiac surgery.

ERAS group Experimental

Enhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin. Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds. Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge.

Criteria 

Inclusion Criteria:

Having Cardiac Surgery
Aged 18 years or older at the time of consent
Deemed appropriate for ERAS by Surgeon and Anaesthetist
Able and willing to provide written informed consent

Exclusion Criteria:

Aged 18 years or under
Deemed not suitable for ERAS by Surgeon and/or Anaesthetist
No Results Posted