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

Phase 1

• 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.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-001552-29-AT
• Lead Sponsor: Medizinische Universität Wien, Abteilung für Anästhesie und allgemeine Intensivmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-20
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

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

All patients
1.Age < 30 or > 60 years2.History of malignant hyperpyrexia3.Cannot ventilate, cannot intubate situation4.CRP prior initiation of sevoflurane
5. Pregnancy and lactation period

Study group
1.High urgency” transplantation2.Acute liver failure3.Hepatic encephalopathy grade IV

Control group
1.History of liver disease2.Abnormal liver specific laboratory parameters3.Laparoscopic surgery

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable