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NCT Number: NCT03576261

Heart Failure and Hemodynamic Stability During Anesthesia Induction

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.

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Key information

Conditions

Hemodynamic Instability Anesthesia; Adverse Effect Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diastolic Dysfunction Heart Diseases Heart Failure Venous; Return (Anomaly)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunderby teaching hospital

Luleå, 97180, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative colloid fluid bolus (Gelofusine)

Other

Preoperative colloid fluid bolus

Preoperative transthoracic echocardiography

Diagnostic Test

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.

Primary outcomes

  1. Incidence of blood pressure drops

    Time frame: 20 minutes post anesthesia induction

    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 .

  2. Incidence of severe blood pressure drops

    Time frame: 20 minutes post anesthesia induction

    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.

Secondary outcomes

  1. Venous return and hemodynamic stability

    Time frame: 20 minutes post anesthesia induction

    Level of venous return impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg

  2. Systolic heart failure and hemodynamic stability

    Time frame: 20 minutes post anesthesia induction

    Systolic heart failure impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg

  3. Diastolic dysfunction and hemodynamic stability

    Time frame: 20 minutes post anesthesia induction

    Diastolic dysfunction impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

Does Heart Failure Has Impact on Hemodynamic Stability During Anesthesia Induction

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 3, 2018
Registry last updated
Dec 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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