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

Primary Purpose

Coronary Artery Disease, Low Cardiac Output Syndrome, Atrial Fibrillation

Status
Active
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Low opioid anesthesia
Sponsored by
Heart Institute, Ministry of Health of Ukraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery bypass grafting, cardiopulmonary bypass, coronary artery disease, low cardiac output syndrome, low-dose opioid anesthesia, postoperarive atrial fibrillation, IL-6

Eligibility Criteria

44 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart Institute Ministry of Health of Ukraine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

First group

Second group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of concentration of IL-6 in venous blood plasma immediately after the 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
Number of people with postoperative atrial fibrillation
Postoperative atrial fibrillation was defined as first appeared in the period immediately after 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%).
The length of ICU stay

Secondary Outcome Measures

Full Information

First Posted
August 19, 2022
Last Updated
August 22, 2022
Sponsor
Heart Institute, Ministry of Health of Ukraine
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1. Study Identification

Unique Protocol Identification Number
NCT05514652
Brief Title
Anesthesia Standard Operating Procedure During On-pump Coronary Artery Bypass Grafting
Official Title
Development of Anesthesia Standard Operating Procedure During On-pump Coronary Artery Bypass Grafting Due to Coronary Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heart Institute, Ministry of Health of Ukraine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First group
Arm Type
Experimental
Arm Description
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.
Arm Title
Second group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Low opioid anesthesia
Intervention Description
Multimodal low-dose opioid protocol for anesthesia based on ketamine, lidocaine and dexmedetomidine
Primary Outcome Measure Information:
Title
Change of concentration of IL-6 in venous blood plasma immediately after the surgery
Time Frame
immediately after surgery
Title
Number of people with low cardiac output syndrome
Description
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
Time Frame
immediately after the surgery
Title
Number of people with postoperative atrial fibrillation
Description
Postoperative atrial fibrillation was defined as first appeared in the period immediately after surgery
Time Frame
immediately after the surgery
Title
Duration of mechanical ventilation
Description
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%).
Time Frame
immediately after the surgery
Title
The length of ICU stay
Time Frame
immediately after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
44 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Heart Institute Ministry of Health of Ukraine
City
Kyiv
State/Province
Kyiv Regio
ZIP/Postal Code
02660
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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