Enhanced Recovery After Surgery (ERAS) in Coronary Artery Bypass Graft / Off Pump Coronary Artery Bypass (CABG/OPCAB)

Study Overview
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Brief Summary
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It has been assumed that some elements of the ERAS protocol may contribute to the reduction of complications and improve the satisfaction of patients undergoing coronary artery bypass surgery. Elements of the ERAS strategy will be tested in this study. The elements that prove to be feasible and have a positive effect on the treatment process will be introduced into everyday clinical practice. In the next stage of the research, we are planning to investigate whether the introduction of the ERAS strategy has had a long-term positive effect on the quality of life after treatment (a survey 1 month and 6 months after leaving the hospital).

Detailed Description
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Evaluation of the impact of implemented elements of the ERAS strategy on the results of surgical treatment of coronary artery disease in the aspect of: preoperative preparation (comprehensive information, premedication, hydration), haemodynamic stability (discontinuation of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers immediately before surgery), optimal pre- and intraoperative fluid therapy, occurrence of respiratory complications (assessment of the duration of mechanical ventilation and passive oxygen therapy), demand for painkillers in the postoperative period, after introducing the preemptive strategy, incidence of postoperative delirium, time to recovery of the normal bowel function (nausea, vomiting), possibility of early mobilisation on the first day after surgery, patient's satisfaction with treatment assessed on the basis of a survey carried out on the day before leaving the hospital.

Official Title
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ERAS Implementation in Coronary Artery Bypass Surgery

Conditions
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Coronary Artery Disease, Coronary Stenosis

Intervention / Treatment
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* Behavioral: Premedication visit
* Dietary Supplement: Preoperative period
* Drug: Preoperative period
* Other: Postoperative period
* Other: Intraoperative period
* Drug: Intraoperative period
* Drug: Intraoperative period
* Drug: Intraoperative period
* Drug: Intraoperative period
* Drug: Intraoperative period


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CABG/OPCAB (Coronary Artery Bypass Surgery/Off Pump Coronary Bypass Surgery). Left ventricular ejection fraction above 35% (EF ≥ 35%). The operation was performed in a planned mode. Exclusion Criteria: Haematological diseases and the associated increased risk of bleeding in the early postoperative period. Patients taking anticoagulants until the day of surgery with the exception of aspirin. Neurological disorders, stroke with persistent symptoms, dementia. Chronic lung disease with hypoxia and the need for regular medication. Inability to move independently, disability preventing efficient rehabilitation, prolonged use of painkillers. Emergency surgery, reoperation. Return to the operating room regardless of the reason (resternotomy). Perioperative infarction with circulatory destabilization.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Implemented ERAS (Early Recovery After Surgery) elements | Behavioral: Premedication visit<br>* detailed information about surgery, anaesthesia and postoperative period<br>Dietary Supplement: Preoperative period<br>* avoidance of prolonged fasting, intake of fluids with carbohydrates before surgery<br>Drug: Preoperative period<br>* administration of melatonin 5 mg in the evening and pregabalin 75 mg one hour before entering the operating theatre<br>Other: Postoperative period<br>* Fluids 1 ml/kg/h; Discontinuation of propofol at the moment of drainage and cardiovascular system stabilization; Fluids administered orally 2 hours after extubation; Early mobilisation<br>Other: Intraoperative period<br>* deep temperature (necessity to maintain normothermia during the stay in the operating theatre 36 °C. Normothermia should be maintained rather than restored.<br>* Other names: Normothermia;Drug: Intraoperative period<br>* Pyralgin 1 g i.v. after induction of anaesthesia; in patients allergic to Pyralginum, Perfalgan 1 g i.v.<br>Drug: Intraoperative period<br>* Ketamine 30 mg i.v. after induction of anaesthesia<br>Drug: Intraoperative period<br>* Sevoflurane 1.5 MAC higher in patients < 60 years old<br>Drug: Intraoperative period<br>* Propofol infusion in patients at risk of postoperative vomiting (Apfel ≥ 2 points), sevoflurane administration at the moments of strong stimuli from the operating field<br>Drug: Intraoperative period<br>* Continuous infusion of balanced multi-electrolyte fluids 1-3 ml/kg/h<br>|
| Control group<br>The control group will consist of patients treated during the study in accordance with the current standards used in the Department | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ERAS bundle compliance in the first 72 hours post-op | Number of interventions for the ERAS protocol that are delivered to patient (numeric data e.g. 5 out of 10) | 72 hours post operation | 
| Shorter Length Of Hospitalization (LOH) | Total amount of days spent in hospital | up to 4 weeks after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative anxiety | Assessment of patient's emotional status according to Anxiety Likert Scale (consisted of five evenly spaced numbers each anchored to a level of anxiety: 1=not at all anxious, 2=a little anxious, 3=moderately anxious, 4=very anxious, 5=extremely anxious) | on admission to the operating unit | 
| Time to extubation | Time taken until patient extubated post operation (in hours) | 0 -72 hours | 
| Assessment of postoperative pain | Pain scores at 6hours, Numeric scale 0 (no pain) - 10 (severe pain) | 0-24 hours | 
| Incidence of postoperative nausea and vomiting | To calculate the PONV Impact Scale score, add the numerical responses to questions 1 and 2. A PONV Impact Scale score of ≥5 defines clinically important PONV (Q1. Have you vomited: 0. No Once Twice Three or more times Q2. Have you experienced a feeling of nausea :0. Not at all 1. Sometimes 2. Often or most of the time 3. All of the time) | At moment 0, 3, 6, 12 and 24 hours after extubation | 
| Time to drink | Time until patient first drinks post extubation (in hours) | 0-72 hours | 
| Time to eating | Time until patient first eats post extubation (in hours) | 0-72 hours | 
| Time to bowel movement | Hours elapsed to event | in hours after extubation, up to 1 week | 
| Incidence of postoperative delirium | Delirium Screening according to Nursing Delirium Screening Scale, Each feature is scored on 0-2 based on severity, with 0=absent, 1=mild, and 2=severe. Positive Nu-DESC is score ≥2, maximum total score is 10 | in hours after extubation, up to 72 hours | 
| Postoperative complications | Rate measurement | up to 2 weeks after surgery | 
| Time to mobilisation | First mobilisation with nurse/physiotherapist post-op (in hours) | 0-72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Bypass Surgery/Grafting, ERAS