Sevoflurane- Safety in Long-term Sedation Procedures

August 18, 2021 updated by: F Javier Belda

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inhalatory sedation
Sevoflurane given via AnaConDa for sedation minimum 48 hours
Drug: Sevoflurane
Sedation with inhaled anesthetic via AnaConDa.
Other Names:
  • Sevorane, Ultane, Sojourn
Active Comparator: Intravenous sedation
Midazolam given intravenously for sedation minimum 48 hours
Drug: Midazolam
Intravenous sedation.
Other Names:
  • Versed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline. Posteriorly, every 12 hours for the full length of sedation. After sedation, every 24 hours up to one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline. Posteriorly, every 12 hours for the full length of sedation. After sedation, every 24 hours up to one week
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.
Baseline. Posteriorly, every 12 hours for the full length of sedation. After sedation, every 24 hours up to one week
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.
Baseline. Posteriorly, every 12 hours for the full length of sedation. After sedation, every 24 hours up to one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

F Javier Belda

Investigators

  • Study Director: Marina Soro, MD, PhD, Hospital Clinico 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

February 9, 2013

First Submitted That Met QC Criteria

February 27, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECSEVO-LT-011
  • 2011-002555-34 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Shared data will be anonymous

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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