Preoperative Volume Substitution in Elective Surgery Patients

Philipps University

Status: Completed

Conditions: Hypovolemia; Hemodynamic Instability; Anesthesia

Treatments: Other: Volume; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT01811966

UKGMVolume (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Control

Sham Comparator group

Description:

preoperative none substitution of i.v. fluids.

Treatment:

Other: Control

Volume

Active Comparator group

Description:

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

Treatment:

Other: Volume