Heart Failure and Hemodynamic Stability During Anesthesia Induction

Study Overview
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Brief Summary
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The study aim is to investigate whether preoperative heart failure has impact on hemodynamic stability during anesthesia induction by target controlled infusion of anesthesia (TCI) in non-cardiac, non-morbidly obese surgery.

Detailed Description
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40 individuals are enrolled to the study after signed informed consent at the day of surgery. The study participants are randomized (non-blinded) to preoperative fluid therapy (preoperative colloid fluid bolus at 6 ml/kg LBW, Gelofusine™, Fresenius Kabi AB, Sweden) or control (no preoperative fluids) before standardized TCI- induction of anesthesia. No other intravenous fluids before anesthesia induction. Preoperative screening of biventricular systolic and diastolic function of the heart and level of venous return is implemented by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.

Official Title
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Does Heart Failure Has Impact on Hemodynamic Stability During Anesthesia Induction

Conditions
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Venous; Return (Anomaly), Hemodynamic Instability, Anesthesia; Adverse Effect, Heart Failure, Diastolic Dysfunction

Intervention / Treatment
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* Other: Preoperative colloid fluid bolus (Gelofusine)
* Diagnostic Test: Preoperative transthoracic echocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 18 years body mass index ≤ 35 kg/m2 electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery Exclusion Criteria: instable angina pectoris severe bronchial asthma severe COPD dementia severe heart valve disease severe renal failure body mass index > 35 kg/m2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A consecutive cohort. Signed informed consent is gathered. Non-blinded randomization is conducted to fluid therapy before anesthesia induction. Preoperative diagnostics by echocardiography is conducted to all participants.Two arms, with or without preoperative fluids, are studied regarding hemodynamic stability during anesthesia induction.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative echo + fluids<br>20 individuals investigated by preoperative transthoracic echocardiography. Preoperative colloid fluid bolus (Gelofusine, Fresenius Kabi AB, Sweden) 6 ml/kg lean body weight, is infused intravenously immediately before anesthesia induction. | Other: Preoperative colloid fluid bolus (Gelofusine)<br>* Preoperative colloid fluid bolus<br>Diagnostic Test: Preoperative transthoracic echocardiography<br>* Screening of biventricular systolic and diastolic function of the heart and level of venous return by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.<br>|
| Active Comparator: Preoperative echo, control<br>20 individuals investigated by preoperative transthoracic echocardiography. No intravenous fluids are infused before anesthesia induction. | Diagnostic Test: Preoperative transthoracic echocardiography<br>* Screening of biventricular systolic and diastolic function of the heart and level of venous return by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of blood pressure drops | Blood pressure drop below mean arterial pressure at 65 mmHg during anesthesia induction. Non-invasive blood pressures (systolic, mean and diastolic) are measured 5 minutes before anesthesia induction and thereafter every 5 minutes post-induction . | 20 minutes post anesthesia induction | 
| Incidence of severe blood pressure drops | Blood pressure drop below mean arterial pressure at 55 mmHg during anesthesia induction. Non-invasive blood pressures (systolic, mean and diastolic) are measured 5 minutes before anesthesia induction and thereafter every 5 minutes post-induction. | 20 minutes post anesthesia induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous return and hemodynamic stability | Level of venous return impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg | 20 minutes post anesthesia induction | 
| Systolic heart failure and hemodynamic stability | Systolic heart failure impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg | 20 minutes post anesthesia induction | 
| Diastolic dysfunction and hemodynamic stability | Diastolic dysfunction impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg | 20 minutes post anesthesia induction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodynamics, venous return, heart failure, anesthesia