Effect of sevoflurane and propofol on hepato-splanchnic pressure and flow during hepatobiliary surgery.

Phase 1

Conditions: patients scheduled for hepato-biliary surgery.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2017-000071-90-BE

Lead Sponsor: Ghent University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 18

Inclusion Criteria

•Adult = 18 years (Female or Male)
•ASA I – II – III
•Able to comprehend, sign and date the written informed consent document to participate in the clinical trial.
•Scheduled for hepato-biliary surgery.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

•Allergy for the medication
•Renal insufficiency (SCr > 2 mg/dl)
•Severe heart failure (EF < 25%)
•Hemodynamic instable patients
•Arterial fibrillation
•Sepsis
•BMI > 40

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective of the study is to compare the effect of sevoflurane and propofol on hepato-splanchnic pressure and blood flow during hepatobiliary surgery. We hypothesized that sevoflurane induces a dose-dependent reduction of hepato-splanchnic blood flow, while propofol increases hepato-splanchnic blood flow.;Secondary Objective: Secondary objective of the study is to compare the need for inotropic and vasopressor support, the amount of colloids administered and blood loss during surgery between the two study groups.;Primary end point(s): The primary end point is to compare Sevoflurane versus propofol on blood flow in the artery hepatica and main portal vein.;Timepoint(s) of evaluation of this end point: End of the surgery.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary end point is to compare Sevoflurane versus propofol the need for inotropic and/or vasopressor support, blood loss and total amount of colloids given.;Timepoint(s) of evaluation of this end point: End of the surgery.