Preoperative Volume Substitution in Elective Surgery Patients
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|ClinicalTrials.gov Identifier: NCT01811966|
Recruitment Status : Completed
First Posted : March 15, 2013
Last Update Posted : July 29, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Hemodynamic Instability Hypovolemia Anesthesia||Other: Volume Other: Control||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Preoperative Volume Substitution in Fasting Patients Undergoing Elective Surgery - Impact on Hemodynamic Stability During Anesthesia|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Sham Comparator: Control
preoperative none substitution of i.v. fluids.
Active Comparator: Volume
preoperative substitution of a defined amount of i.v. fluids (8 ml/kg RingerAcetate solution for 15 min prior to introduction of anesthesia).
- hemodynamic instability [ Time Frame: 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
- Stroke volume index > 35 ml/m2 [ Time Frame: at time of anesthesia ]
- Stroke volume variation < 12 % [ Time Frame: at time of anesthesia ]
- Enddiastolic area (EDA) > 10 cm2 [ Time Frame: at time of anesthesia ]transthoracic echocardiographic parasternal short axis enddiastolic area
- inferior vana cava diameter (VCI) > 15 mm [ Time Frame: at time of anesthesia ]transthoracic echocardiographic inferior vena cava diameter
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811966
|University Hospital of Marburg, Department of Anesthesia|
|Marburg, Germany, D-35033|
|Principal Investigator:||Thomas Kratz, MD||Department of Anesthesia and Intensive Care Medicine, University Hospital Marburg, Germany|