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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772106
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

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.


Condition or disease Intervention/treatment Phase
General Anesthesia Drug: Propofol Fresenius Drug: sevorane Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Effect of Sevoflurane and Propofol on Hepato-splanchnic Pressure and Flow During Hepatobiliary Surgery
Actual Study Start Date : June 8, 2017
Actual Primary Completion Date : January 27, 2018
Actual Study Completion Date : December 4, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group P
Group P : Propolipid 1% dose : variable to keep BIS between 40 and 60
Drug: Propofol Fresenius
Propolipid 1% : IV

Experimental: Group S
Group S : Sevoflurane dose : variable to keep BIS between 40 and 60
Drug: sevorane
sevorane Quick fill (sevoflurane) : inhalation




Primary Outcome Measures :
  1. Change in blood flow in hepatic artery and main portal vein [ Time Frame: From randomization until the end of the whipple surgery ]
    flow/pressure measurements with echo probe and needle


Secondary Outcome Measures :
  1. need of inotropic and/or vasopressor support [ Time Frame: From start anesthesia until end of anesthesia ]
    total dose of inotropic and vasopressor medication that were used during surgery

  2. amount of blood loss [ Time Frame: From start of surgery until end of surgery ]
    amount of blood loss at end of surgery

  3. amount of colloids given during surgery [ Time Frame: From start of surgery until end of surgery ]
    total amount of colloids given during surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772106


Locations
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Belgium
University Hospital Ghent
Gent, Oost-Vlaanderen, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Jurgten Van Limmen, MD UZ Ghent
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03772106    
Other Study ID Numbers: 2017/0164
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Ghent:
hepato-splanchnic blood flow
Additional relevant MeSH terms:
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Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation