Study on the safety of administration of sevoflurane for long-term sedation in critical patients on assisted ventilation.

• Conditions: The general objective of this study is to perform an assessment of the safety of administration of sevoflurane for prolonged sedation of patients admitted to the Critical Care Unit.; MedDRA version: 14.0Level: SOCClassification code 10042613Term: Surgical and medical proceduresSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2011-002555-34-ES
• Lead Sponsor: FRANCISCO JAVIER BELDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Signing of the informed consent document (patient or relatives).
- Patient age 18 years or older.
- Expected minimum duration of sedation: 48 hours.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- Known allergy to any of the study drugs.
- Patients with known or suspected genetic susceptibility to malignant hyperthermia.
- Renal failure (3 AKIN classification)
- Liver failure: C Chaild-Pugh.
- History of chronic alcohol abuse or neurological disease.
- Pregnant or breastfeeding women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified