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

NCT ID: NCT05514652

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2022-12-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

First group

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.

Group Type: EXPERIMENTAL

Low opioid anesthesia

Intervention Type: DRUG

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

Second group

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.

Group Type: ACTIVE_COMPARATOR

Low opioid anesthesia

Intervention Type: DRUG

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

Interventions

Low opioid anesthesia

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 44 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart Institute, Ministry of Health of Ukraine

OTHER

Sponsor Role: lead

Responsible Party

Maruniak Stepan

Senior Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Heart Institute Ministry of Health of Ukraine

Kyiv, Kyiv Regio, Ukraine

Countries

Ukraine

References

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.

Reference Type: DERIVED

PMID: 37803334 (View on PubMed)

Other Identifiers

20180001

Identifier Type: -

Identifier Source: org_study_id