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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03576261
Other study ID # 2016/361-31 III
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2018
Est. completion date December 2, 2021

Study information

Verified date December 2021
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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, Gelofusineā„¢, 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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date December 2, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Other:
Preoperative colloid fluid bolus (Gelofusine)
Preoperative colloid fluid bolus
Diagnostic Test:
Preoperative transthoracic echocardiography
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.

Locations

Country Name City State
Sweden Sunderby teaching hospital Luleå

Sponsors (1)

Lead Sponsor Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
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