Status:
WITHDRAWN
Sevoflurane- Safety in Long-term Sedation Procedures
Lead Sponsor:
F Javier Belda
Conditions:
Poisoning by Inhaled Anaesthetic
Fluoride Poisoning
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 s...
Eligibility Criteria
Inclusion
- Signing of the informed consent document (patient or relatives).
- Patient age 18 years or older.
- Expected minimum duration of sedation: 48 hours.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01802255
Start Date
March 1 2013
End Date
June 1 2015
Last Update
August 24 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010