Preoperative Volume Substitution in Elective Surgery Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Hypovolemia; Hemodynamic Instability
• Intervention / Treatment: Other: Control; Other: Volume

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Marburg, Germany, D-35033
    • University Hospital of Marburg, Department of Anesthesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at time of introduction of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke volume index > 35 ml/m2		at time of anesthesia
Stroke volume variation < 12 %		at time of anesthesia
Enddiastolic area (EDA) > 10 cm2	transthoracic echocardiographic parasternal short axis enddiastolic area	at time of anesthesia
inferior vana cava diameter (VCI) > 15 mm	transthoracic echocardiographic inferior vena cava diameter	at time of anesthesia

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Investigators: Principal Investigator: Thomas Kratz, MD, Department of Anesthesia and Intensive Care Medicine, University Hospital Marburg, Germany

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: March 13, 2013
• First Submitted That Met QC Criteria: March 14, 2013
• First Posted (ESTIMATE): March 15, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 29, 2015
• Last Update Submitted That Met QC Criteria: July 28, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: preoperative fasting; hypovolemia; preoperative volume substitution
• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia
• Other Study ID Numbers: UKGMVolume (OTHER: University Hospital of Marburg)