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Completed

NCT Number: NCT01811966

Preoperative Volume Substitution in Elective Surgery Patients

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.

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Key information

Conditions

Hemodynamic Instability Anesthesia Hypovolemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Marburg, Department of Anesthesia

Marburg, D-35033, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Volume

Other

Other names: RingerAcetate Solution, cristalloide

Control

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Registry information

Official study title

Preoperative Volume Substitution in Fasting Patients Undergoing Elective Surgery - Impact on Hemodynamic Stability During Anesthesia

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 15, 2013
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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