Sevoflurane- Safety in Long-term Sedation Procedures

F Javier Belda

Status and phase

Withdrawn

Phase 3

Conditions

Recovery From Sedation

Renal Function

Poisoning by Inhaled Anaesthetic

Hepatic Function

Fluoride Poisoning

Treatments

Drug: Sevoflurane

Drug: Midazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT01802255

ECSEVO-LT-011

2011-002555-34 (EudraCT Number)

Details and patient eligibility

About

Patients needing intensive care often require sedative drugs to reduce anxiety and agitation during ventilator care and invasive therapeutic and diagnostic procedures. At present there is no optimal sedative agent for these patients. The most commonly used sedative agents in intensive care units are midazolam and propofol. Both drugs have side effects of clinical importance.

At present, a viable alternative to intravenous sedation is inhalatory sedation. Sevoflurane, as other inhaled anesthetic agents, is sedative in low doses. A new simplified method of administration of isoflurane or sevoflurane has been developed. The Anesthetic Conserving Device is a modified heat-moisture exchanger (HME) that permits direct infusion of sevoflurane to the airway, where it is vaporized in an evaporator rod in the device.

However, the use of sevoflurane is limited to anesthesia and sedation lasting no more than 12 hours, since the possible renal problems posed by inorganic fluoride in prolonged operations remain the subject of controversy.

The primary aim (and primary hypothesis) of the current trial is to determine whether sevoflurane can be administered as a sedative drug for more than 48 hours without clinically relevant physiopathological effects on kidney and liver function.

Other end-points of the trial are to evaluate the quality of sedation of sevoflurane, in terms of sedation control, the rapidity and predictability of awakening, and the incidence of delirium in critical care patients.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signing of the informed consent document (patient or relatives).
Patient age 18 years or older.
Expected minimum duration of sedation: 48 hours.

Exclusion criteria

Chronic renal failure treated with replacement therapy (hemodialysis or peritoneal dialysis).
Acute kidney injury in Stage 3 of AKIN classification
Grade C hepatic Child-Pugh classification
Established Acute Respiratory Distress Syndrome (ARDS).
Central nervous system pathology with cognitive disorders that not allow performing the test of the study: severe dementia, Alzheimer's disease, depression, schizophrenia, acute stroke.
Head trauma with Glasgow <12.
Patient treated with antiepileptic drugs that must be maintained during the study period
Patients requiring the use of neuromuscular blocking agents during the infusion of study drug, except for the insertion of the endotracheal tube.
Epidural or spinal analgesia
Allergy or known hypersensitivity to any of the study drugs
Patients with known or suspected genetic susceptibility to malignant hyperthermia
Previous participation in this trial
Participation in another clinical trial within 4 weeks prior to selection.
Pregnant women