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UnknownNCT03956420

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

ERAS Implementation in Coronary Artery Bypass Surgery

Status
Unknown
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Silesian University of Medicine · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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).

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPremedication visitdetailed information about surgery, anaesthesia and postoperative period
DIETARY_SUPPLEMENTPreoperative periodavoidance of prolonged fasting, intake of fluids with carbohydrates before surgery
DRUGPreoperative periodadministration of melatonin 5 mg in the evening and pregabalin 75 mg one hour before entering the operating theatre
OTHERPostoperative periodFluids 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
OTHERIntraoperative perioddeep temperature (necessity to maintain normothermia during the stay in the operating theatre 36 °C. Normothermia should be maintained rather than restored.
DRUGIntraoperative periodPyralgin 1 g i.v. after induction of anaesthesia; in patients allergic to Pyralginum, Perfalgan 1 g i.v.
DRUGIntraoperative periodKetamine 30 mg i.v. after induction of anaesthesia
DRUGIntraoperative periodSevoflurane 1.5 MAC higher in patients \< 60 years old
DRUGIntraoperative periodPropofol infusion in patients at risk of postoperative vomiting (Apfel ≥ 2 points), sevoflurane administration at the moments of strong stimuli from the operating field
DRUGIntraoperative periodContinuous infusion of balanced multi-electrolyte fluids 1-3 ml/kg/h

Timeline

Start date
2019-05-03
Primary completion
2020-01-01
Completion
2021-05-01
First posted
2019-05-20
Last updated
2019-05-20

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT03956420. Inclusion in this directory is not an endorsement.