Sevoflurane- Safety in Long-term Sedation Procedures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01802255|
Recruitment Status : Recruiting
First Posted : March 1, 2013
Last Update Posted : March 24, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Poisoning by Inhaled Anaesthetic Fluoride Poisoning Recovery From Sedation Renal Function Hepatic Function||Drug: Sevoflurane Drug: Midazolam||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|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.|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Inhalatory sedation
Sevoflurane given via AnaConDa for sedation minimum 48 hours
Sedation with inhaled anesthetic via AnaConDa.
Other Name: Sevorane, Ultane, Sojourn
Active Comparator: Intravenous sedation
Midazolam given intravenously for sedation minimum 48 hours
Other Name: Versed
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802255
|Contact: F Javier Belda, MD, PhDfirstname.lastname@example.org|
|Hospital Clínico Universitario de Valencia||Recruiting|
|Valencia, Spain, 46010|
|Contact: F Javier Belda, MD, PhD|
|Study Director:||Marina Soro, MD, PhD||Hospital Clínico Universitario de Valencia|
|Principal Investigator:||Luciano Aguilera, MD, PhD||Hospital de Basurto|
|Principal Investigator:||Carlos Soria, MD, PhD||Complejo Asistencial de León|
|Principal Investigator:||Francisco Acosta, MD, PhD||Hospital Universitario Virgen de la Arrixaca|