An interventional study of Preoperative colloid fluid bolus (Gelofusine) and Preoperative transthoracic echocardiography in Hemodynamic Instability, Anesthesia; Adverse Effect and Heart Failure, sponsored by Umeå University. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-16.
Sponsored by Umeå University · Not applicable, Interventional, and Other
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.
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.
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This study's enrollment of 44 is below the median of 72 across 3,733 interventional studies indexed under Heart Failure.
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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) · Diagnostic Test: Preoperative transthoracic echocardiography
20 individuals investigated by preoperative transthoracic echocardiography. No intravenous fluids are infused before anesthesia induction.
Diagnostic Test: Preoperative transthoracic echocardiography
Preoperative colloid fluid bolus
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.
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 .
Time frame: 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.
Time frame: 20 minutes post anesthesia induction
Venous return and hemodynamic stability
Level of venous return impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg
Time frame: 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
Time frame: 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
Time frame: 20 minutes post anesthesia induction
Plan to share: No
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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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