Preoperative Volume Substitution in Elective Surgery Patients

Not Applicable

Completed

• Conditions: Hemodynamic Instability; Anesthesia; Hypovolemia
• Interventions: Other: Control; Other: Volume

• Registration Number: NCT01811966
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-14
• Study First Posted: 2013-03-15
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-28
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	preoperative none substitution of i.v. fluids.
Volume	Volume	preoperative substitution of a defined amount of i.v. fluids (8 ml/kg RingerAcetate solution for 15 min prior to introduction of anesthesia).

Primary Outcome Measures

Name	Time	Method
hemodynamic instability	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

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

Trial Locations

Locations (1)

University Hospital of Marburg, Department of Anesthesia; 🇩🇪 Marburg, Germany