General AnesthesiaPhase 4NCT03772106
Effect of Sevoflurane and Propofol on Hepato-splanchnic Pressure and Flow During Hepatobiliary Surgery
A Phase 4 study testing Propofol Fresenius and sevorane in people with General Anesthesia, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Propofol Fresenius and sevorane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Jun 2017to 4 Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Allergy for the medication
- Renal insufficiency (SCr > 2 mg/dl)
- Severe heart failure (EF < 25%)
- Hemodynamic instable patients
- Arterial fibrillation
- Sepsis
Show all 10Show fewer
- BMI > 40
- Severe coagulopathy (INR > 2)
- Thrombocytopenia (< 80 x 10³ /µL)
- History of severe postoperative nausea \& vomiting
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- General Anesthesia
- Being tested
- Propofol Fresenius, sevorane
- Keywords
- hepato-splanchnic blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol FreseniusDrug
Propolipid 1% : IV
sevoraneDrug
sevorane Quick fill (sevoflurane) : inhalation
| Study group | Role | What they receive |
|---|---|---|
| Group P | Experimental | Group P : Propolipid 1% dose : variable to keep BIS between 40 and 60 Receives: Drug: Propofol Fresenius |
| Group S | Experimental | Group S : Sevoflurane dose : variable to keep BIS between 40 and 60 Receives: Drug: sevorane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood flow in hepatic artery and main portal vein
flow/pressure measurements with echo probe and needle
Measured: From randomization until the end of the whipple surgery
Secondary outcomes (3)
need of inotropic and/or vasopressor support
total dose of inotropic and vasopressor medication that were used during surgery
Measured: From start anesthesia until end of anesthesia
amount of blood loss
amount of blood loss at end of surgery
Measured: From start of surgery until end of surgery
amount of colloids given during surgery
total amount of colloids given during surgery
Measured: From start of surgery until end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start8 Jun 2017
- Primary completion27 Jan 2018
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jurgten Van Limmen, MD, Principal investigator, UZ Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772106
- Sponsor's protocol ID
- 2017/0164
- Status last verified
- Dec 2018
- First submitted
- 4 Dec 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32962657
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sevoflurane and Propofol on Hepato-splanchnic Pressure and Flow During Hepatobiliary Surgery
- ClinicalTrials.gov ID
- NCT03772106
- Acronym / sponsor ID
- 2017/0164
- Conditions
- General Anesthesia
- Keywords
- hepato-splanchnic blood flow
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 27 Jan 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P | Experimental | Drug: Propofol FreseniusGroup P : Propolipid 1% dose : variable to keep BIS between 40 and 60 |
| Group S | Experimental | Drug: sevoraneGroup S : Sevoflurane dose : variable to keep BIS between 40 and 60 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- Allergy for the medication
- Renal insufficiency (SCr > 2 mg/dl)
- Severe heart failure (EF < 25%)
- Hemodynamic instable patients
- Arterial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol FreseniusPropolipid 1% : IV | Drug | Group P |
| sevoranesevorane Quick fill (sevoflurane) : inhalation | Drug | Group S |
Primary outcome
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
3 secondary outcomes
need of inotropic and/or vasopressor support
Time frame: From start anesthesia until end of anesthesia
amount of blood loss
Time frame: From start of surgery until end of surgery
amount of colloids given during surgery
Time frame: From start of surgery until end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Derived from this study: PubMed 32962657van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jurgten Van Limmen, MD principal investigator
UZ Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol Fresenius and sevorane in people with General Anesthesia, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood flow in hepatic artery and main portal vein (time frame: From randomization until the end of the whipple surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03772106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.