Determination of the minimal alveolar concentration of Sevoflurane in patient with end stage liver disease

Determination of the minimal alveolar concentration of Sevoflurane in patient with end stage liver disease - MAC of sevoflurane during liver transplantation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001552-29-AT

Enrollment

Registered

2014-05-20

Start date

2014-06-20

Completion date

Unknown

Last updated

2021-05-03

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

Conditions

Orthotopic liver transplantation (OLT) is the only therapy for patients with liver failure. These patients have reduced anesthetic requirements compared with healthy patients. Sevoflurane has proven safe use for anesthesia during OLT. It has a known minimum alveolar concentration (MAC) in healthy adults ranging from 1.7 to 2.1%. However, the MAC of sevoflurane is unknown in patients liver failure The aim of this study was to determine the MAC of sevoflurane in patients undergoing OLT.

Interventions

Trade Name: Sevoflurane Baxter Product Name: Sevoflurane Pharmaceutical Form: Inhalation vapour INN or Proposed INN: sevoflurane CAS Number: 28523-86-6 Other descriptive name: SEVOFLURANE Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Study Group (OLT) 1. first OLT 2. chronic liver failure Control Group 1. Abdominal surgery 2. required skin incision of at least 10cm 3. Transaminases within normal range 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 48 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: All patients 1. Age 60 years 2. History of malignant hyperpyrexia 3. Cannot ventilate, cannot intubate situation 4. CRP prior initiation of sevoflurane 5. Pregnancy and lactation period Study group 1. “High urgency” transplantation 2. Acute liver failure 3. Hepatic encephalopathy grade IV Control group 1. History of liver disease 2. Abnormal liver specific laboratory parameters 3. Laparoscopic surgery

Design outcomes

Primary

Measure	Time frame
Main Objective: to determine whether patients with end stage liver disease undergoing liver transplantation have lower MAC values of sevoflurane than healthy patients.;Secondary Objective: not applicable;Primary end point(s): Determination of MAC by observation of patients' reaction to initial skin incision. Patients' reaction is defined as gross movement or no movement of arms, legs or head within 1 minute after the skin incision.;Timepoint(s) of evaluation of this end point: Observation period starting with skin incision and ending after 1 minute	—

Measure

Time frame

Main Objective: to determine whether patients with end stage liver disease undergoing liver transplantation have lower MAC values of sevoflurane than healthy patients.;Secondary Objective: not applicable;Primary end point(s): Determination of MAC by observation of patients' reaction to initial skin incision. Patients' reaction is defined as gross movement or no movement of arms, legs or head within 1 minute after the skin incision.;Timepoint(s) of evaluation of this end point: Observation period starting with skin incision and ending after 1 minute

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Austria

Contacts

Public ContactSekretariat

Medizinische Universität Wien, Abteilung für Anästhesie und allgemeine Intensivmedizin

00431404004102

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026