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

Coronary Artery Disease Clinical Trial

Official title:

ERAS Implementation in Coronary Artery Bypass Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03956420
• Other study ID #: KNW/0022/KB1/26/18
• Status: Enrolling by invitation
• Start date: May 3, 2019
• Est. completion date: May 2021

Study information

• Verified date: May 2019
• Source: Silesian University of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: May 2021
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis
• Myocardial Ischemia

Intervention

Behavioral:
• Premedication visit
detailed information about surgery, anaesthesia and postoperative period

Dietary Supplement:
• Preoperative period
avoidance of prolonged fasting, intake of fluids with carbohydrates before surgery

Drug:
• Preoperative period
administration of melatonin 5 mg in the evening and pregabalin 75 mg one hour before entering the operating theatre

Other:
• 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.

Drug:
• 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

Locations

Country	Name	City	State
Poland	Upper-Silesian Medical Centre of the Silesian Medical University	Katowice	Polska

Sponsors (1)

Lead Sponsor	Collaborator
Silesian University of Medicine

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Recovery	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	1 and 6 months after operation
Primary	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
Primary	Shorter Length Of Hospitalization (LOH)	Total amount of days spent in hospital	up to 4 weeks after operation
Secondary	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
Secondary	Time to extubation	Time taken until patient extubated post operation (in hours)	0 -72 hours
Secondary	Assessment of postoperative pain	Pain scores at 6hours, Numeric scale 0 (no pain) - 10 (severe pain)	0-24 hours
Secondary	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
Secondary	Time to drink	Time until patient first drinks post extubation (in hours)	0-72 hours
Secondary	Time to eating	Time until patient first eats post extubation (in hours)	0-72 hours
Secondary	Time to bowel movement	Hours elapsed to event	in hours after extubation, up to 1 week
Secondary	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
Secondary	Postoperative complications	Rate measurement	up to 2 weeks after surgery
Secondary	Time to mobilisation	First mobilisation with nurse/physiotherapist post-op (in hours)	0-72 hours