Enhanced Recovery After Cardiac Surgery

NCT03859102 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-09-27

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03859102 on ClinicalTrials.gov