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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
Sponsor:
Information provided by (Responsible Party):
Dr. Thomas Kratz, Philipps University Marburg Medical Center

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.


Condition or disease Intervention/treatment Phase
Hemodynamic Instability Hypovolemia Anesthesia Other: Volume Other: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Sham Comparator: Control
preoperative none substitution of i.v. fluids.
Other: Control
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).
Other: Volume
Other Names:
  • RingerAcetate Solution
  • cristalloide




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Stroke volume index > 35 ml/m2 [ Time Frame: at time of anesthesia ]
  2. Stroke volume variation < 12 % [ Time Frame: at time of anesthesia ]
  3. Enddiastolic area (EDA) > 10 cm2 [ Time Frame: at time of anesthesia ]
    transthoracic echocardiographic parasternal short axis enddiastolic area

  4. inferior vana cava diameter (VCI) > 15 mm [ Time Frame: at time of anesthesia ]
    transthoracic echocardiographic inferior vena cava diameter



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Locations
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Germany
University Hospital of Marburg, Department of Anesthesia
Marburg, Germany, D-35033
Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
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Principal Investigator: Thomas Kratz, MD Department of Anesthesia and Intensive Care Medicine, University Hospital Marburg, Germany

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Responsible Party: Dr. Thomas Kratz, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT01811966    
Other Study ID Numbers: UKGMVolume
UKGMVolume ( Other Identifier: University Hospital of Marburg )
First Posted: March 15, 2013    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015
Keywords provided by Dr. Thomas Kratz, Philipps University Marburg Medical Center:
preoperative volume substitution
hypovolemia
preoperative fasting
Additional relevant MeSH terms:
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Hypovolemia
Pathologic Processes