The general objective of this study is to perform an assessment of the safety of administration of sevoflurane for prolonged sedation of patients admitted to the Critical Care Unit. MedDRA version: 14.0 Level: SOC Classification code 10042613 Term: Surgical and medical procedures System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Sevorane
Product Name: SEVOFLURANE
Product Code: 12164-005
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: sevorane
CAS Number: 28523-86-6
Current Sponsor code: sevoran
Sponsors
FRANCISCO JAVIER BELDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signing of the informed consent document (patient or relatives). - Patient age 18 years or older. - Expected minimum duration of sedation: 48 hours. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - Known allergy to any of the study drugs. - Patients with known or suspected genetic susceptibility to malignant hyperthermia. - Renal failure (3 AKIN classification) - Liver failure: C Chaild-Pugh. - History of chronic alcohol abuse or neurological disease. - Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether sevoflurane, an inhalatory anesthetic used in anesthesia procedures with a maximum duration of 12 hours, can be administered as a sedative for over 48 hours without clinically relevant physiopathological effects upon kidney and liver function.;Secondary Objective: To compare the quality of sedation afforded by sevoflurane versus midazolam, in terms of sedation control, the rapidity and predictability of awakening, and the incidence of delirium in critical care patients.;Primary end point(s): Determinations for evaluating renal function: Measurements in plasma: creatinine, cystatin C, urea, uric acid and erythropoietin. Measurements in urine: creatinine, creatinine clearance, glucose, proteins, albumin, sodium and osmolarity.;Timepoint(s) of evaluation of this end point: Sampling timepoints: - Baseline: immediately before starting to administer the sedating agent. - Posteriorly, sampling will be made every 12 hours for the full length of sedation. - After suspending sedation, sampling will be repeated during 7 days every 24 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. SGOT (aspartate aminotransferase, AST), SGPT (alanine aminotransferase, ALT), LDH (lactate dehydrogenase) alkaline phosphatase, conjugated and total bilirubin, cholesterol, triglycerides, albumin, total proteins, electrolytes and glycogen. 3. Quality of sedation;Timepoint(s) of evaluation of this end point: 1 Plasma fluoride levels and Liver function markers: - Baseline: immediately before starting to administer the sedating agent. - Posteriorly, sampling will be made every 12 hours for the full length of sedation. - After suspending sedation, sampling will be repeated during 7 days every 24 hours. 2. The assessment Quality of sedation Before starting administration of the study sedative drug. - Every hour since the time of start of administration of the drug continuing until the end of infusion. - After discontinuing the study drug, every 4 hours the first 24 hours. | — |
Countries
Spain
Contacts
Public ContactCritical Care Department. Hospital
Francisco Javier Belda
Outcome results
None listed