Preoperative Volume Substitution in Elective Surgery Patients
Primary Purpose
Hemodynamic Instability, Hypovolemia, Anesthesia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Volume
Control
Sponsored by
About this trial
This is an interventional treatment trial for Hemodynamic Instability focused on measuring preoperative volume substitution, hypovolemia, preoperative fasting
Eligibility Criteria
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)
Sites / Locations
- University Hospital of Marburg, Department of Anesthesia
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Control
Volume
Arm Description
preoperative none substitution of i.v. fluids.
preoperative substitution of a defined amount of i.v. fluids (8 ml/kg RingerAcetate solution for 15 min prior to introduction of anesthesia).
Outcomes
Primary Outcome Measures
hemodynamic instability
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 Outcome Measures
Stroke volume index > 35 ml/m2
Stroke volume variation < 12 %
Enddiastolic area (EDA) > 10 cm2
transthoracic echocardiographic parasternal short axis enddiastolic area
inferior vana cava diameter (VCI) > 15 mm
transthoracic echocardiographic inferior vena cava diameter
Full Information
NCT ID
NCT01811966
First Posted
March 13, 2013
Last Updated
July 28, 2015
Sponsor
Philipps University Marburg Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01811966
Brief Title
Preoperative Volume Substitution in Elective Surgery Patients
Official Title
Preoperative Volume Substitution in Fasting Patients Undergoing Elective Surgery - Impact on Hemodynamic Stability During Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodynamic Instability, Hypovolemia, Anesthesia
Keywords
preoperative volume substitution, hypovolemia, preoperative fasting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
preoperative none substitution of i.v. fluids.
Arm Title
Volume
Arm Type
Active Comparator
Arm Description
preoperative substitution of a defined amount of i.v. fluids (8 ml/kg RingerAcetate solution for 15 min prior to introduction of anesthesia).
Intervention Type
Other
Intervention Name(s)
Volume
Other Intervention Name(s)
RingerAcetate Solution, cristalloide
Intervention Type
Other
Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
hemodynamic instability
Description
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
Time Frame
at time of introduction of anesthesia
Secondary Outcome Measure Information:
Title
Stroke volume index > 35 ml/m2
Time Frame
at time of anesthesia
Title
Stroke volume variation < 12 %
Time Frame
at time of anesthesia
Title
Enddiastolic area (EDA) > 10 cm2
Description
transthoracic echocardiographic parasternal short axis enddiastolic area
Time Frame
at time of anesthesia
Title
inferior vana cava diameter (VCI) > 15 mm
Description
transthoracic echocardiographic inferior vena cava diameter
Time Frame
at time of anesthesia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kratz, MD
Organizational Affiliation
Department of Anesthesia and Intensive Care Medicine, University Hospital Marburg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Marburg, Department of Anesthesia
City
Marburg
ZIP/Postal Code
D-35033
Country
Germany
12. IPD Sharing Statement
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Preoperative Volume Substitution in Elective Surgery Patients
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