Number of interventions for the ERAS protocol that are delivered to patient (numeric data e.g. 5 out of 10)
Enhanced Recovery After Surgery (ERAS) in Coronary Artery Bypass Graft / Off Pump Coronary Artery Bypass (CABG/OPCAB)
Brief Summary
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).
Intervention / Treatment
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Premedication visit (BEHAVIORAL)detailed information about surgery, anaesthesia and postoperative period
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Preoperative period (DRUG)administration of melatonin 5 mg in the evening and pregabalin 75 mg one hour before entering the operating theatre
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Postoperative period (OTHER)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
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Intraoperative period (DRUG)Continuous infusion of balanced multi-electrolyte fluids 1-3 ml/kg/h
Condition or Disease
- Coronary Artery Disease
- Coronary Stenosis
Phase
Study Design
| Study type: | OBSERVATIONAL |
|---|---|
| Status: | Unknown status |
| Study results: | No Results Available |
| Age: | Child, Adult, Older Adult |
| Enrollment: | 100 (ACTUAL) |
| Funded by: | Other |
| Time Perspective: | Prospective |
| Observational Model: | Case-Control |
Masking |
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Clinical Trial Dates
| Start date: | May 03, 2019 | ACTUAL |
|---|---|---|
| Primary Completion: | Jan 01, 2020 | ESTIMATED |
| Completion Date: | May 01, 2021 | ESTIMATED |
| Study First Posted: | May 20, 2019 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | May 17, 2019 |
Sponsors / Collaborators
Lead Sponsor:
Silesian University of Medicine
Responsible Party:
N/A
Location
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.
* 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.
Participant Groups
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Implemented ERAS (Early Recovery After Surgery) elements
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The control group will consist of patients treated during the study in accordance with the current standards used in the Department
Eligibility Criteria
| Sex: | All |
|---|---|
| Age Groups: | Child / Adult / Older Adult |
| Healthy Volunteers: | Yes |
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.
* 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.
Primary Outcomes
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Total amount of days spent in hospital
Secondary Outcomes
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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)
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Time taken until patient extubated post operation (in hours)
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Pain scores at 6hours, Numeric scale 0 (no pain) - 10 (severe pain)
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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 1. Once 2. Twice 3. 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)
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Time until patient first drinks post extubation (in hours)
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Time until patient first eats post extubation (in hours)
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Hours elapsed to event
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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
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Rate measurement
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First mobilisation with nurse/physiotherapist post-op (in hours)
Other Outcomes
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This process resulted in the QoR-15 questionnaire ( Part A: How have you been feeling in the last 24 hours; 0-10 0-poor, 10 - excellent; rated areas: breath,food,feeling rested, sleep, hygiene,communicate, getting support, return to work, feeling comfortable, well-being; Part B Have you had any of following in the last 24h: modreate pain, severe pain, nause or vomiting, feeling worried, feeling sad; 10-0, 10 - none of the time, 0 - all of the time
More Details
| NCT Number: | NCT03956420 |
|---|---|
| Other IDs: | KNW/0022/KB1/26/18 |
| Study URL: | https://clinicaltrials.gov/study/NCT03956420 |
Last updated: Sep 29, 2023