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Obesity and Goal-directed Intraoperative Fluid Therapy

Intraoperative Goal-directed Fluid Management in Non-Obese and Obese Patients Undergoing Laparoscopic Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01052519
Enrollment
90
Registered
2010-01-20
Start date
2010-01-31
Completion date
2014-06-30
Last updated
2014-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Esophageal Doppler monitoring, tissue oxygen tension

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.

Interventions

Fluid will be administered to reach maximal stroke volume during the intraoperative period.

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Subcutaneous tissue oxygenationintraoperative and 2 postoperative hours

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026