Clinical Trial: Sevoflurane- Safety in Long-term Sedation Procedures

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:
Sponsor: F Javier Belda

Current Primary Outcome: Maintenance of renal function. [ Time Frame: Baseline. Posteriorly, every 12 hours for the full length of sedation. After sedation, every 24 hours up to one week ]

Measurements in plasma: creatinine and cystatin levels.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Assessment of liver function [ Time Frame: Baseline. Posteriorly, every 12 hours for the full length of sedation. After sedation, every 24 hours up to one week ]
    Measurements in plasma: 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.
  • Plasma pharmacokinetics of fluoride [ Time Frame: Baseline. Posteriorly, every 12 hours for the full length of sedation. After sedation, every 24 hours up to one week ]
    Determine evolutionary plasmatic levels of fluorides.
  • Incidence of delirium [ Time Frame: Baseline. Posteriorly, every 12 hours for the full length of sedation. After sedation, every 24 hours up to one week ]
    The incidence of delirium will be evaluated by the CAM-ICU method.


Original Secondary Outcome: Same as current

Information By: Fundación para la Investigación del Hospital Clínico de Valencia

Dates:
Date Received: February 9, 2013
Date Started: March 2013
Date Completion: June 2020
Last Updated: March 23, 2017
Last Verified: March 2017