Completed

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

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What is being tested

Control

+ Volume

Other
Who is being recruted

Pathologic Processes

+ Pathological Conditions, Signs and Symptoms

+ Hypovolemia

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorPhilipps University Marburg
Last updated: July 29, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01811966
Principal SponsorPhilipps University Marburg
Last updated: July 29, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

220 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pathologic ProcessesPathological Conditions, Signs and SymptomsHypovolemia

Criteria

3 inclusion criteria required to participate
Age >= 18 years
general anesthesia
thyreoid, parathyroid or gallbladder surgery
6 exclusion criteria prevent from participating
cerebrovascular disease
congestive heart disease ( >= New York Heart Association (NYHA) 2)
coronary artery disease
insulin dependent diabetes mellitus
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Sham
preoperative none substitution of i.v. fluids.

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University Hospital of Marburg, Department of Anesthesia

Marburg, GermanyOpen University Hospital of Marburg, Department of Anesthesia in Google Maps
CompletedOne Study Center