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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.

Primary Purpose

Post Induction Hypotension

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ringer acetate
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Induction Hypotension

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Kasr Al Ainy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Volume loading

Control

Arm Description

Outcomes

Primary Outcome Measures

Incidence of post-induction hypotension
Incidence of post-induction hypotension from start of induction of anesthesia till 15-minutes

Secondary Outcome Measures

Incidence of post-induction hypertension, bradycardia, and tachycardia
Incidence of post-induction hypertension, bradycardia, and tachycardia

Full Information

First Posted
July 14, 2022
Last Updated
July 14, 2022
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05462847
Brief Title
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.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Volume loading
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ringer acetate
Intervention Description
8ml/kg Ringer acetate over 10 minutes
Primary Outcome Measure Information:
Title
Incidence of post-induction hypotension
Description
Incidence of post-induction hypotension from start of induction of anesthesia till 15-minutes
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Incidence of post-induction hypertension, bradycardia, and tachycardia
Description
Incidence of post-induction hypertension, bradycardia, and tachycardia
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman Abougabal
Organizational Affiliation
lecturer of anesthesia Kasr Al Ainy hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Al Ainy
City
Cairo
ZIP/Postal Code
12566
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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.

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