Anesthesia Standard Operating Procedure During On-pump Coronary Artery Bypass Grafting

NCT05514652 | Unknown DMC

• 1 other identifier: 20180001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Despite improvements in surgical and anesthesia procedures over the past 15 years complications during cardiac surgery still remain high. Bridgewater B et al. describes mortality during on-pump coronary artery bypass grafting (CABG) at 2%-3%, and the rate postoperative complications about 20%-30%. At the same time, the standard of care in patients undergoingon-pump CABG is not fully established. Hypothesis, Research Need: Use of multimodal low-dose opioid anesthesia during CABG decreases inflammatory response and the incidence of early postoperative cardiac complications due to a reduction in interleukin-6. Methodology: According to anesthesia standard protocol, all patients were divided into two groups - study group with multimodal low-dose opioid anesthesia (60 patients) and control group with a high-dose opioid anesthesia (60 patients). Primary (IL-6 at the end of the operation) and secondary clinical outcomes (postoperative atrial fibrillation (POAF), low cardiac output syndrome (LCOS), duration of mechanical ventilation (MV), length of intensive care unit (ICU) stay, length of hospital stay) were compared between the groups. Analysis Tools: Clinical observations; instrumental research methods (electrocapdiography, echocardiography); labs (blood gases, hemoglobin, electrolytes); enzyme-linked immunosorbent assay (IL-6); statistical (Student's t-test, Mann-Whitney U test, χ2-test, correlation analysis). Expected Outcomes: Use of multimodal low-dose opioid anesthesia during CABG will decrease inflammatory response (lower levels of IL-6 at the end of the surgery) and the incidence of early postoperative cardiac complications, expressed as lower incidence of LCOS and POAF, lower duration of MV and lower length of ICU stay.

Conditions

Coronary Artery Disease; Low Cardiac Output Syndrome; Atrial Fibrillation; Postoperative Complications

Keywords

coronary artery bypass grafting; cardiopulmonary bypass; coronary artery disease; low cardiac output syndrome; low-dose opioid anesthesia; postoperarive atrial fibrillation; IL-6

Outcome Measures

Primary Outcomes (5)

• Change of concentration of IL-6 in venous blood plasma immediately after the surgery

  immediately after surgery

• Number of people with low cardiac output syndrome

  Postoperative low cardiac output syndrome (LCOS) was defined as hemodynamic instability requiring continued pharmacologic support with 2 inotropic medications (epinephrine, milrinone, dobutamine) on postoperative day 1

  immediately after the surgery

• Number of people with postoperative atrial fibrillation

  Postoperative atrial fibrillation was defined as first appeared in the period immediately after surgery

  immediately after the surgery

• Duration of mechanical ventilation

  The decision about the extubation was made on the basis of following clinical criteria: recovering from muscle relaxation and anesthesia; patients is easy to rouse, neurologically intact, lift head and sticks out tongue; stable hemodynamics (heart rate and blood pressure are within ordered parameters, bleeding is controlled); spontaneous muscle movement with stable respiratory rate and adequate oxygenation, which was confirmed by arterial blood gases (SaO2 \>92 %, on FiO2 \<50%).

  immediately after the surgery

• The length of ICU stay

  immediately after the surgery

Study Arms (2)

First group

EXPERIMENTAL

Multimodal low-opioid protocol provided for induction of anesthesia with intravenous (iv) propofol administration using the dosage of 1.5-2 mg/kg at 40 mg in interval of 10-15 seconds, iv fentanyl dosage 1-1.5 μg/kg and iv pipecuronium bromide dosage of 0.1 mg/kg. Before intubation of the trachea, a lidocaine 1 mg / kg bolus was added intravenously, with the simultaneous establishment of a continuous infusion at a dose of 1.5-2 mg/kg/h. All patients were administered a bolus of ketamine (0.5 mg/kg) and were started continuous infusion dexmedetomidine at a dose 0.7 μg/kg/h. If indicated fentanyl was used as additional analgesic during surgery by bolus injection. Depth of anesthesia was monitored with bispectral index; the dosage of sevoflurane from 1,5vol% to 2,5vol% was titrated to maintain BIS values from 40 to 60.

Drug: Low opioid anesthesia

Second group

ACTIVE COMPARATOR

Routine opioid protocol of anesthesia provided for induction of anesthesia with the iv administration of propofol dosage of 1.5-2 mg/kg at 40 mg in interval of 15-20 seconds, iv fentanyl at a dose of 1-1.5 μg/kg and iv pipecuronium bromide dosage of 0.1 mg/kg. For analgesia, bolus injections of fentanyl were used at a dose of 8-10 μg/kg for the entire duration of the operation, muscle relaxation - pipecuronium bromide at a dose of 0.1 mg/kg. Depth of anesthesia was monitored with bispectral index; the dosage of sevoflurane from 1,5vol% to 2,5vol% was titrated to maintain BIS values from 40 to 60.

Drug: Low opioid anesthesia

Interventions

Low opioid anesthesia DRUG

Multimodal low-dose opioid protocol for anesthesia based on ketamine, lidocaine and dexmedetomidine

First group; Second group

Eligibility Criteria

• Age: 44 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age from 44 to 65 years,
• nn ejection fraction \> 30%,
• operational risk assessment for EuroSCORE II \<5%,
• on-pump coronary artery bypass grafting

You may not qualify if:

• patient's refusal
• off-pump coronary artery bypass grafting
• the need for additional intervention on the heart

Sponsors & Collaborators

• Heart Institute, Ministry of Health of Ukraine: lead

Study Sites (1)

Heart Institute Ministry of Health of Ukraine

Kyiv, Kyiv Regio, 02660, Ukraine

Location

Related Publications (1)

• Stepan M, Oleh L, Oleksandr D, Justyna S. Effects of multimodal low-opioid anesthesia protocol during on-pump coronary artery bypass grafting: a prospective cohort study. J Cardiothorac Surg. 2023 Oct 6;18(1):272. doi: 10.1186/s13019-023-02395-y.

  PMID: 37803334 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Cardiac Output, Low; Atrial Fibrillation; Postoperative Complications

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 24, 2022
• Study Start: December 1, 2018
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2022
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)