Comparing the Hemodynamic Effects of Volume Loading vs Non-loading During Induction of Anesthesia in Fluid Responder Patients With Coronary Artery Disease Undergoing Elective Coronary Artery Bypass Graft Surgery: a Randomized Controlled Study.

All preoperative cardiac medications will be continued till the morning of the surgery, except angiotensin converting enzyme inhibitors. Patients will be pre-medicated with intramuscular morphine at 0.1 mg.kg-1 one hour before surgery. Upon arrival to the operating room, Initial monitoring included five lead electrocardiograms, non-invasive blood pressure, and pulse oximetry. At the attending anesthetists discretion, intravenous midazolam (0.05 mg/kg) will be administered for anxiolysis. Under local anesthesia an arterial line will be placed in the right radial artery and central venous line will be placed in the right internal jugular vein.

Before induction of anesthesia for all study patients, Electrical cardiometry device (ICON; Cardiotonic, Osypka; Berlin, Germany) will be applied to the patient through 4 electrodes at the following sites: Below the left ear, Above the midpoint of the left clavicle, Left mid-axillary line at level of the xiphoid process and 5 cm inferior to the third electrode. Stroke volume variability (SVV) was measured while patient maintaining standard calm breathing at 8 breath/minute for one-minute. Patients with SVV less than 13% will be excluded from the study. Thus, all patients included will be considered fluid responders[5]. The baseline data in the form of heart rate, systolic, diastolic, and mean systemic arterial pressures, CO, CI, SV, SVI, SVV, SVR, and SVRI will be recorded during the study period in all the patients.

Patients will then be randomly divided into two groups; control group will receive nothing before induction, while patients in volume loading group will receive volume loading of 8ml/kg Ringer acetate over 10 minutes. The volume loading will be repeated until SVV would be below 13%. The volume loading would be given by an anesthesia resident not involved in data collection.

For induction, Patients in both groups will receive 3 mcg/kg of fentanyl. Then in all patients, propofol will be injected slowly at 1.5 mg/kg in 0.25 mg/kg increments every 20 s till clinical loss of consciousness. Clinical loss of consciousness (defined as no response to auditory command) will be assessed by asking the patients repeatedly every 20 s to open their eyes. After loss of consciousness, atracurium 0.5 mg/kg will be administered to facilitate tracheal intubation. The stress response to laryngoscopy and tracheal intubation is secondary to marked increase in sympathetic activity and manifested in general as tachycardia and hypertension and will be managed with increments 0..25mcg fentanyl. Hemodynamic changes; 20 beats/ minute or 20 mmHg difference in heart rate and blood pressure respectively were considered to be significant. Anesthesia will be maintained by isoflurane (1-1.2 %). Patients will be mechanically ventilated to have target of PO2 above 300mmhg and PCO2 between 35-40mmg.

Any episode of hypotension (defined as mean arterial pressure [MAP] < 80% of the baseline reading and/or MAP <60 mmHg) will be managed by 5 mcg norepinephrine (which could be repeated if hypotension persists for 2 minutes).

If bradycardia occurred (defined as heart rate less than 50 bpm), it will be managed by IV atropine bolus (0.5 mg).

Hemodynamic data will be recorded 1-minte before the induction, 1-and 2-minutes after loss of consciousness, 1-minutes after intubation, then every 2-minutes for 15-minutes after intubation., the end point of the present study. Throughout this period the lungs will be mechanically ventilated with 50% air-oxygen mixture, to maintain an end-tidal carbon dioxide between 35 and 40 mmHg.

Study Overview

• Status: Completed
• Conditions: Post Induction Hypotension
• Intervention / Treatment: Drug: Ringer acetate

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12566
    • Kasr Al Ainy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with coronary artery disease ASA physical status III-IV scheduled for elective CABG surgery.

Exclusion Criteria:

• • left ventricular systolic dysfunction (LVSD) <40%,

  • persistent serious arrhythmias,
  • congestive cardiac failure, on mechanical ventilation,
  • intra-aortic balloon pump (IABP),
  • emergency surgery,
  • un controlled diabetes (HbA1C >8)
  • those with known allergy to any of the study's drugs,
  • severe systemic non-cardiac disease,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control	Drug: Ringer acetate; 8ml/kg Ringer acetate over 10 minutes
EXPERIMENTAL: Volume loading	Drug: Ringer acetate; 8ml/kg Ringer acetate over 10 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of post-induction hypotension	Incidence of post-induction hypotension from start of induction of anesthesia till 15-minutes	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of post-induction hypertension, bradycardia, and tachycardia	Incidence of post-induction hypertension, bradycardia, and tachycardia	15 minutes

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Principal Investigator: Ayman Abougabal, lecturer of anesthesia Kasr Al Ainy hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2021
• Primary Completion (ACTUAL): May 1, 2022
• Study Completion (ACTUAL): May 1, 2022

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (ACTUAL): July 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hypotension
• Other Study ID Numbers: MS-618-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No