Trial | NCT01802255  Report issue

Title

Sevoflurane- Safety in Long-term Sedation Procedures
Study of the Safety of Administration of Sevoflurane for Long-term Critically Ill Patients Sedation Undergoing Mechanical Ventilation. Prospective, Controlled, Randomized, Multicenter, Clinical Trial.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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.
Study Started
Mar 31
2013
Primary Completion
Jan 31
2015
Anticipated
Study Completion
Jun 30
2015
Anticipated
Last Update
Aug 24
2021

Drug Sevoflurane

Sedation with inhaled anesthetic via AnaConDa.

  • Other names: Sevorane, Ultane, Sojourn

Drug Midazolam

Intravenous sedation.

  • Other names: Versed

Inhalatory sedation Experimental

Sevoflurane given via AnaConDa for sedation minimum 48 hours

Intravenous sedation Active Comparator

Midazolam given intravenously for sedation minimum 48 hours

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.

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
No Results Posted