Enhanced Recovery After Cardiac Surgery

NCT03859102 | Unknown

• 1 other identifier: IRAS242926
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Enhanced recovery after Surgery; ERAS; Enhanced Recovery after Cardiac Surgery; Cardiac Surgery; Coronary Artery Bypass graft; Aortic Valve Surgery; Mitral Valve Surgery; Aortic Root Surgery

Outcome Measures

Primary Outcomes (1)

• ERAS bundle compliance in the first 48hours post-op

  Number of interventions for the ERAS protocol that are delivered to patient (numeric data e.g. 6 out of 10)

  48hours post op

Secondary Outcomes (7)

• Time to extubation

  0-24hours

• Time to mobilisation

  0-48hours

• Time to oral diet

  0-48hours

• Post-op pain

  6hours

• Post-op pain

  12hours

Study Arms (2)

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.

Dietary Supplement: Pre-operative Carbohydrate PreLoad drink; Drug: Oral Gabapentin pre-op; Drug: Oral Lansoprazole pre-op; Drug: Intravenous Paracetamol intra-operatively; Drug: Intravenous Dexamethasone intra-operatively; Drug: Intravenous Ondansetron intra-operatively; Drug: Infiltration of surgical wounds with local anaesthetic; Drug: Intravenous Magnesium intra-operatively; Drug: Post-operative Gabapentin analgesia; Drug: Post-operative oral Paracetamol analgesia; Drug: Post-operative Ondansetron anti-emesis; Procedure: Early extubation; Procedure: Early mobilisation/physiotherapy; Other: Encourage early oral food intake

Interventions

Pre-operative Carbohydrate PreLoad drink DIETARY_SUPPLEMENT

Pre-operative Carbohydrate PreLoad drink, 1 sachet given the night before surgery. One sachet given 2-4hours before surgery.

ERAS group

Oral Gabapentin pre-op DRUG

One dose of Gabapentin pre-operatively, 300mg orally.

ERAS group

Oral Lansoprazole pre-op DRUG

One dose of Lansoprazole pre-operatively, 30mg orally.

ERAS group

Intravenous Paracetamol intra-operatively DRUG

One dose of Paracetamol intra-operatively, 1gram intravenous infusion.

ERAS group

Intravenous Dexamethasone intra-operatively DRUG

One dose of Dexamethasone intra-operatively as an anti-emetic, 8mg intravenous.

ERAS group

Intravenous Ondansetron intra-operatively DRUG

One dose of Ondansetron intra-operatively as an anti-emetic, 4mg intravenous

ERAS group

Infiltration of surgical wounds with local anaesthetic DRUG

Infiltration of surgical wounds with local anaesthetic at the end of surgery, Bupivacaine 1-2mg/kg.

ERAS group

Intravenous Magnesium intra-operatively DRUG

One infusion of intravenous Magnesium Sulphate intra-operatively as an analgesic, 50mg/kg given over 30minutes.

ERAS group

Post-operative Gabapentin analgesia DRUG

Post-operative oral Gabapentin 300mg, three times daily as an analgesic.

ERAS group

Post-operative oral Paracetamol analgesia DRUG

Post-operative Paracetamol as an analgesic. Initially intravenously, then orally. One gram four times daily.

ERAS group

Post-operative Ondansetron anti-emesis DRUG

Intravenous Ondansetron administered post-operatively as prophylactic anti-emesis. 4mg three times daily, for 24 hours. Then as required.

ERAS group

Early extubation PROCEDURE

Removal of the endotracheal tube in the Intensive Care Unit as soon as is safe.

ERAS group

Early mobilisation/physiotherapy PROCEDURE

Mobilisation (active and passive limb movements, deep breathing) with the assistance of nurse/physiotherapist to occur as soon as possible post-operatively.

ERAS group

Encourage early oral food intake OTHER

Patients will be encouraged to start eating as soon as possible post-operatively

ERAS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Aged 18 years or under
• Deemed not suitable for ERAS by Surgeon and/or Anaesthetist

Sponsors & Collaborators

• James Cook University Hospital: lead
• Medela AG: collaborator

Study Sites (1)

James Cook University Hospital

Middlesbrough, Teeside, TS4 3BW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Valve Disease

Interventions

Anesthesia, Local; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Therapeutics; Rehabilitation

Study Officials

• Jim C Coates, MBBS

  James Cook University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jim C Coates, MBBS

CONTACT

01642854630; james.coates1@nhs.net

Adrian Mellor, MBBS

CONTACT

01642850850; adrian.mellor@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow in Cardiothoracic Anaesthesia

Model Details: Sequential prospective cohort study

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: March 1, 2019
• Study Start: December 17, 2018
• Primary Completion: October 1, 2019
• Study Completion: November 29, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)