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Effect of Sevoflurane and Propofol on Hepato-splanchnic Pressure and Flow During Hepatobiliary Surgery

Effect of Sevoflurane and Propofol on Hepato-splanchnic Pressure and Flow During Hepatobiliary Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03772106
Enrollment
29
Registered
2018-12-11
Start date
2017-06-08
Completion date
2018-12-04
Last updated
2018-12-11

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

Conditions

General Anesthesia

Keywords

hepato-splanchnic blood flow

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.

Interventions

Propolipid 1% : IV

sevorane Quick fill (sevoflurane) : inhalation

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

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

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Change in blood flow in hepatic artery and main portal veinFrom randomization until the end of the whipple surgeryflow/pressure measurements with echo probe and needle

Secondary

MeasureTime frameDescription
need of inotropic and/or vasopressor supportFrom start anesthesia until end of anesthesiatotal dose of inotropic and vasopressor medication that were used during surgery
amount of blood lossFrom start of surgery until end of surgeryamount of blood loss at end of surgery
amount of colloids given during surgeryFrom start of surgery until end of surgerytotal amount of colloids given during surgery

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026