Clinical trial NCT03772106: Effect of Sevoflurane and Propofol on Hepato-splanchnic Pressure and Flow During Hepatobiliary Surgery
Official title: Effect of Sevoflurane and Propofol on Hepato-splanchnic Pressure and Flow During Hepatobiliary Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: General Anesthesia
Keywords: hepato-splanchnic blood flow
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Blood loss in hepatobiliary surgery is correlated with an increase in postoperative complications (e.g. transfusion related lung injury and tumor recurrence) and reduced longterm survival. To reduce morbidity and mortality in hepatobiliary surgery, modulation of the hepato-splanchnic blood flow and pressure is used. In liver surgery pharmacological modulations are widely used to prevent blood loss. For pharmacological modulation central venous pressure is commonly used to reduce the pressure in the inferior vena cava, however little is known about pharmacological effect on blood flow in the hepatic artery and portal vein. The modulation of the hepato-splanchnic blood flow can also play an important role, not only for prevention of blood loss but also for survival of the organs (e.g. ischemic injury due to low flow).

Volatile anesthetics induce a dose-dependent reduction of the hepato-splanchninc blood flow. Propofol however, increases hepatic blood flow when compared with volatile anesthetics. Pharmacological modulation of hepato-splanchnic bloodflow with anesthetics such as sevoflurane or propofol can play an important role in modulation of ischemia/reperfusion injury and survival of organs.

The aim of the study is to determine and to compare the effect of sevoflurane versus propofol on hepatosplanchnic pressure and hepato-splanchnic blood flow during hepatobiliary surgery.

Detailed description: All patients receive standardized anesthesia care for hepato-biliary surgery according to the existing anesthesia protocol. The type of anaesthesia will be randomized : propolipid (TIV) or sevorane(inhalation).

At designated times, hemodynamic variables will be recorded.

These will include:

* HF (/min)
* CVP (mmHg),
* MAP (mmHg)
* CI (L/min.m2)
* PPV (pulse pressure variation). Hemodynamic measurement will be done using PiCCO catheter.

The hemodynamic measurements will be compared and related to hepato-splanchnic blood flow and pressure measurements performed by the surgeon:

* Flow v. porta
* Flow art. hepatica
* Pressure v. porta
* Pressure v. cava The flow measurements will be done using ultrasound transit time ﬂow measurements TTFM (Medi-Stim AS, Oslo, Norway).

At the same time pressure measurements will be obtained in portal vein and caval vein using a 25-gauge needle which is directly placed in the vein. Both flow and pressure will be simultaneously recorded (VeriQ 4122, Medi-Stim AS, Oslo, Norway). Both measurements will be done during apnea to minimize the effect of ventilation on pressure \& flow. Flow values will be expressed in ml per minute, pressure values will be expressed in mmHg.

Eligibility criteria: 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.

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
* Severe coagulopathy (INR \> 2)
* Thrombocytopenia (\< 80 x 10³ /µL)
* History of severe postoperative nausea \& vomiting

Primary outcomes:
measure: Change in blood flow in hepatic artery and main portal vein
timeFrame: From randomization until the end of the whipple surgery
Secondary outcomes:
measure: need of inotropic and/or vasopressor support
timeFrame: From start anesthesia until end of anesthesia
measure: amount of blood loss
timeFrame: From start of surgery until end of surgery
measure: amount of colloids given during surgery
timeFrame: From start of surgery until end of surgery
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: University Hospital Ghent
state: Oost-Vlaanderen
Study officials:
affiliation: UZ Ghent
name: Jurgten Van Limmen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Limmen J, Wyffels P, Berrevoet F, Vanlander A, Coeman L, Wouters P, De Hert S, De Baerdemaeker L. Effects of propofol and sevoflurane on hepatic blood flow: a randomized controlled trial. BMC Anesthesiol. 2020 Sep 22;20(1):241. doi: 10.1186/s12871-020-01150-3.