Enhanced Recovery After Surgery (ERAS) in Coronary Artery Bypass Graft / Off Pump Coronary Artery Bypass (CABG/OPCAB)
NCT ID: NCT03956420
Last Updated: 2019-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2019-05-03
2021-05-31
Brief Summary
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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).
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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Study group
Implemented ERAS (Early Recovery After Surgery) elements
Premedication visit
detailed information about surgery, anaesthesia and postoperative period
Preoperative period
avoidance of prolonged fasting, intake of fluids with carbohydrates before surgery
Preoperative period
administration of melatonin 5 mg in the evening and pregabalin 75 mg one hour before entering the operating theatre
Postoperative period
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
Intraoperative period
deep temperature (necessity to maintain normothermia during the stay in the operating theatre 36 °C. Normothermia should be maintained rather than restored.
Intraoperative period
Pyralgin 1 g i.v. after induction of anaesthesia; in patients allergic to Pyralginum, Perfalgan 1 g i.v.
Intraoperative period
Ketamine 30 mg i.v. after induction of anaesthesia
Intraoperative period
Sevoflurane 1.5 MAC higher in patients \< 60 years old
Intraoperative period
Propofol infusion in patients at risk of postoperative vomiting (Apfel ≥ 2 points), sevoflurane administration at the moments of strong stimuli from the operating field
Intraoperative period
Continuous infusion of balanced multi-electrolyte fluids 1-3 ml/kg/h
Control group
The control group will consist of patients treated during the study in accordance with the current standards used in the Department
No interventions assigned to this group
Interventions
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Premedication visit
detailed information about surgery, anaesthesia and postoperative period
Preoperative period
avoidance of prolonged fasting, intake of fluids with carbohydrates before surgery
Preoperative period
administration of melatonin 5 mg in the evening and pregabalin 75 mg one hour before entering the operating theatre
Postoperative period
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
Intraoperative period
deep temperature (necessity to maintain normothermia during the stay in the operating theatre 36 °C. Normothermia should be maintained rather than restored.
Intraoperative period
Pyralgin 1 g i.v. after induction of anaesthesia; in patients allergic to Pyralginum, Perfalgan 1 g i.v.
Intraoperative period
Ketamine 30 mg i.v. after induction of anaesthesia
Intraoperative period
Sevoflurane 1.5 MAC higher in patients \< 60 years old
Intraoperative period
Propofol infusion in patients at risk of postoperative vomiting (Apfel ≥ 2 points), sevoflurane administration at the moments of strong stimuli from the operating field
Intraoperative period
Continuous infusion of balanced multi-electrolyte fluids 1-3 ml/kg/h
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Left ventricular ejection fraction above 35% (EF ≥ 35%).
* The operation was performed in a planned mode.
Exclusion Criteria
* 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.
ALL
No
Sponsors
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Silesian University of Medicine
OTHER
Responsible Party
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Ewa Kucewicz-Czech
Clinical Professor, Head of Unit
Principal Investigators
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Ewa Kucewicz-Czech
Role: STUDY_CHAIR
Upper-Silesian Medical Centre; DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE WITH CARDIAC MONITORING
Locations
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Upper-Silesian Medical Centre of the Silesian Medical University
Katowice, Polska, Poland
Countries
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Other Identifiers
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KNW/0022/KB1/26/18
Identifier Type: -
Identifier Source: org_study_id
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