Preoperative Volume Substitution in Elective Surgery Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hemodynamic Instability Hypovolemia Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

preoperative none substitution of i.v. fluids.

Group Type SHAM_COMPARATOR

Control

Intervention Type OTHER

Volume

preoperative substitution of a defined amount of i.v. fluids (8 ml/kg RingerAcetate solution for 15 min prior to introduction of anesthesia).

Group Type ACTIVE_COMPARATOR

Volume

Intervention Type OTHER

Interventions

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Volume

Intervention Type OTHER

Control

Intervention Type OTHER

Other Intervention Names

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RingerAcetate Solution cristalloide

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No