Comparison between sedation obtained with Sevoflurane administered through inhalation and Propofol administered through intravenous infusio

Phase 1

Active, not recruiting

• Conditions: Preoperative-scheduled sedation in surgical patients admitted in the Intensive Care Unit (ICU) for postoperative monitoring; MedDRA version: 21.1Level: LLTClassification code 10049124Term: Sedation during medical procedureSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-003225-15-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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.

Study & Design

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