Hemodynamic Instability, Hypovolemia, Anesthesia
Conditions
Keywords
preoperative volume substitution, hypovolemia, preoperative fasting
Brief summary
Preoperative fasting can evoke a hypovolemia which may cause a hemodynamic instability during introduction of anesthesia. The purpose of this study is to test the hypothesis that a defined preoperative volume substitution compared to standard procedure will result in a reduced incidence of hemodynamic instabilities during introduction of anesthesia in elective surgery patients.
Detailed description
The preoperative fasting period often lasts longer than 2 hours as recommended by various national and international anesthetic guidelines. Thus, hypovolemia is more often then anticipated. In awake patients this condition is often masked. Introduction of anesthesia often leads to an unmasking of hypovolemia with a consecutive hemodynamic instability. Aim of the study is to test the hypothesis that a preoperative volume substitution (8 ml/kg RingerAcetate Solution in 15 min. prior to introduction of anesthesia) reduces possible hemodynamic instabilities during initiation of anesthesia.
Interventions
OTHERVolume
OTHERControl
Sponsors
Philipps University Marburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * thyreoid, parathyroid or gallbladder surgery * general anesthesia
Exclusion criteria
* coronary artery disease * congestive heart disease (≥ New York Heart Association (NYHA) 2) * insulin dependent diabetes mellitus * renal insufficiency (creatinine \> 2,0 mg/dl) * cerebrovascular disease * severe hypertension (≥ antihypertensive drugs)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hemodynamic instability | at time of introduction of anesthesia | Hemodynamic instability during induction of anesthesia (0-10 min), defined as at least one of the following: * Systolic blood pressure \< 80 mmHg or decrease of 20% in preexistent hypertension * Mean blood pressure \< 50 mmHg or decrease of 20% or \> 20 mmHg in preexistent hypertension * Bradycardia \< 45/min or decrease of 20% in preexistent bradycardia \< 60/min. * Tachycardia \> 120/min * Cardiac index \< 2.0 l/min/m² |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke volume index > 35 ml/m2 | at time of anesthesia | — |
| Stroke volume variation < 12 % | at time of anesthesia | — |
| Enddiastolic area (EDA) > 10 cm2 | at time of anesthesia | transthoracic echocardiographic parasternal short axis enddiastolic area |
| inferior vana cava diameter (VCI) > 15 mm | at time of anesthesia | transthoracic echocardiographic inferior vena cava diameter |
Countries
Germany
Outcome results
None listed