Preoperative Volume Substitution in Elective Surgery Patients

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811966
• Other study ID #: UKGMVolume
• Secondary ID: UKGMVolume
• Status: Completed
• Phase: N/A
• First received: March 13, 2013
• Last updated: July 28, 2015
• Start date: March 2013
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Hemodynamic Instability
• Hypovolemia

Intervention

Other:
• Volume

• Control

Locations

Country	Name	City	State
Germany	University Hospital of Marburg, Department of Anesthesia	Marburg

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Stroke volume index > 35 ml/m2		at time of anesthesia	No
Secondary	Stroke volume variation < 12 %		at time of anesthesia	No
Secondary	Enddiastolic area (EDA) > 10 cm2	transthoracic echocardiographic parasternal short axis enddiastolic area	at time of anesthesia	No
Secondary	inferior vana cava diameter (VCI) > 15 mm	transthoracic echocardiographic inferior vena cava diameter	at time of anesthesia	No