Clinical trial NCT01052519: Obesity and Goal-directed Intraoperative Fluid Therapy
Official title: Intraoperative Goal-directed Fluid Management in Non-Obese and Obese Patients Undergoing Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Esophageal Doppler monitoring
tissue oxygen tension
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2010-01-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare non-obese patients (BMI≤ 30 kg/m2)versus obese patients (BMI\> 30 kg/m2) in regard of their respective needs for intraoperative fluid therapy during laparoscopic surgery.

Specifically the investigators will test the hypothesis that subcutaneous tissue oxygenation (PsqO2)is increased in obese patients when fluid management is optimized by means of esophageal Doppler monitoring compared to obese patients undergoing standard fluid management.

Furthermore the investigators will test the hypothesis that PsqO2 is decreased in obese patients undergoing conventional fluid therapy compared to non-obese patients when fluid management is optimized. Thus the investigators assume that PsqO2 is similar in obese and non-obese patients when fluid management is optimized in both groups.

Detailed description: Hemodynamic stability and normovolemia are critical determinants of tissue perfusion and oxygenation. Adequate tissue oxygenation is essential to maintain normal physiologic functions and to reduce complications, such as wound infections.

Fat tissue is relatively hypoperfused and, therefore, poorly oxygenated. Subcutaneous tissue oxygenation in the obese is thus critically low and even supplemental oxygen only slightly increases subcutaneous oxygenation.It is likely that poor subcutaneous oxygenation in the obese surgical patients results in part from inadequate intraoperative fluid replacement.

It remains unknown how to hydrate obese surgical patients best. The most physiologic approach for perioperative fluid replacement is now thought to be goal-directed management, using stroke volume as the treatment parameter.

Eligibility criteria: Inclusion Criteria:

* Non-obese (BMI≤ 30kg/m2) and obese patients (BMI \> 30 kg/m2)
* undergoing laparoscopic elective fundoplication or elective bariatric surgery

Exclusion Criteria:

* decompensate heart failure
* documented coronary artery disease
* renal insufficiency
* severe chronic obstructive pulmonary disease
* symptoms of infection or sepsis
* esophageal disease (excepting gastro-esophageal reflux without any other esophageal alteration).

Primary outcomes:
measure: Subcutaneous tissue oxygenation
timeFrame: intraoperative and 2 postoperative hours
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Anesthesiology, Medical University of Vienna
Study officials:
affiliation: MUW
name: Barbara Kabon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kabon B, Nagele A, Reddy D, Eagon C, Fleshman JW, Sessler DI, Kurz A. Obesity decreases perioperative tissue oxygenation. Anesthesiology. 2004 Feb;100(2):274-80. doi: 10.1097/00000542-200402000-00015.
citation: Fleischmann E, Kurz A, Niedermayr M, Schebesta K, Kimberger O, Sessler DI, Kabon B, Prager G. Tissue oxygenation in obese and non-obese patients during laparoscopy. Obes Surg. 2005 Jun-Jul;15(6):813-9. doi: 10.1381/0960892054222867.
citation: Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
citation: Muhlbacher J, Luf F, Zotti O, Herkner H, Fleischmann E, Kabon B. Effect of Intraoperative Goal-Directed Fluid Management on Tissue Oxygen Tension in Obese Patients: a Randomized Controlled Trial. Obes Surg. 2021 Mar;31(3):1129-1138. doi: 10.1007/s11695-020-05106-x. Epub 2020 Nov 27.