Heart Failure and Hemodynamic Stability During Anesthesia Induction

Not Applicable

Completed

• Conditions: Hemodynamic Instability; Diastolic Dysfunction; Anesthesia; Adverse Effect; Venous; Return (Anomaly); Heart Failure
• Interventions: Other: Preoperative colloid fluid bolus (Gelofusine); Diagnostic Test: Preoperative transthoracic echocardiography

• Registration Number: NCT03576261
• Lead Sponsor: Umeå University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-06-04
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-03
• Study Start: 2018-08-01
• Status Verified: 2021-12
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-02
• Last Update Submitted: 2021-12-15
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative echo + fluids	Preoperative transthoracic echocardiography	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.
Preoperative echo + fluids	Preoperative colloid fluid bolus (Gelofusine)	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.
Preoperative echo, control	Preoperative transthoracic echocardiography	20 individuals investigated by preoperative transthoracic echocardiography. No intravenous fluids are infused before anesthesia induction.

Primary Outcome Measures

Name	Time	Method
Incidence of severe blood pressure drops	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.
Incidence of blood pressure drops	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 .

Secondary Outcome Measures

Name	Time	Method
Diastolic dysfunction and hemodynamic stability	20 minutes post anesthesia induction	Diastolic dysfunction impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg
Venous return and hemodynamic stability	20 minutes post anesthesia induction	Level of venous return impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg
Systolic heart failure and hemodynamic stability	20 minutes post anesthesia induction	Systolic heart failure impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg

Trial Locations

Locations (1)

Sunderby teaching hospital; 🇸🇪 Luleå, Sweden