EUCTR2017-003225-15-IT
Active, not recruiting
Phase 1
Comparison between inhaled sedation with Sevoflurane vs endovenous sedation with Propofol in the Intensive Care Unit: a randomized prospective trial - HALO-IC
ConditionsPreoperative-scheduled sedation in surgical patients admitted in the Intensive Care Unit (ICU) for postoperative monitoringMedDRA version: 21.1Level: LLTClassification code 10049124Term: Sedation during medical procedureSystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Preoperative-scheduled sedation in surgical patients admitted in the Intensive Care Unit (ICU) for postoperative monitoring
- Sponsor
- AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Consent, obtained during the preoperative period, for data treatment , randomization and participation in the study.
- •Age \> 18 years
- •Pre\-operative indications for post\-operative monitoring in the ICU
- •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 20
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 20
Exclusion Criteria
- •Pregnancy and breast feeding (women of childbearing age will be tested for the beta\-HCG dosage to certainy exclude the pregnancy before the enrollment).
- •Known hypersensitivity to propofol, soy, peanut or any of the excipients of the emulsion, as well as allergic patients to soy or peanut.
- •Patients undergoing treatment with Cyclosporine.
- •Severe or suspected hypersensitivity to sevoflurane or other halogenated anesthetics (eg history of liver dysfunction, fever or leukocytosis of unknown cause after anesthesia with one of these agents).
- •Moderate to severe hepatic dysfunction due to jaundice, fever, and eosinophilia after Sevoflurane\-induced anesthesia.
- •Genetic predisposition known or suspected of malignant hyperthermia.
Outcomes
Primary Outcomes
Not specified
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