Hemodynamic Stability During Induction of Anaesthesia

Study Overview
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Brief Summary
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The study aim is to investigate if preoperative volume bolus based on lean body weight could preserve mean arterial pressure during target controlled infusion of anaesthesia (TCI) or rapid sequence induction of anaesthesia (RSI) in non-cardiac, non-morbidly obese surgery.

Detailed Description
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40 individuals are enrolled to TCI and RSI groups respectively. The randomization process for preoperative fluid bolus prior to induction of anaesthesia is conducted in respective group at the day of surgery. Preoperative colloid fluid therapy (6 ml/kg LBW, Gelofusine™, Fresenius Kabi Ab, Sweden) is infused rapidly before non-invasive baseline blood pressure (NIBP) measurements in twenty individuals in each group. No other intravenous fluids before induction of anaesthesia. NIBPs, pulse frequency, peripheral saturation (SpO2) are registered and collected 20 minutes post induction.

Official Title
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Hemodynamic Stability During an Induction of Anaesthesia: A Randomized, Non-blinded Study

Conditions
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Hemodynamic Instability, Fluid Therapy, Anesthesia; Adverse Effect

Intervention / Treatment
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* Other: gelofusine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 80 individuals 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 at the day of surgery, severe bronchial asthma or COPD.

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: Single Group Assignment
Interventional Model Description: Non-blinded randomization. Standardized method comparison.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative fluids<br>40 individuals receiving preoperative colloid fluid bolus at 6 ml/kg LBW, (Gelofusine™, Fresenius Kabi AB, Sweden) before anesthesia induction by TCI (n = 20) or RSI (n =20). | Other: gelofusine<br>* Preoperative colloid fluid bolus 6ml/kg ideal body weight<br>* Other names: colloid fluid;|
| No Intervention: No preoperative fluids<br>40 individuals anesthetized by TCI (n = 20) or RSI (n =20) without preoperative fluids. | |

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 | 20 minutes post anesthesia induction | 
| Effect of preoperative fluid bolus | Does preoperative fluid bolus decrease incidence of blood pressure drops | 20 minutes post anesthesia induction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preoperative, fluid therapy, hemodynamics, anesthesia induction, rapid sequence induction, TCI