EVALUATION OF THE EFFICACY OF INHALATORY SEDATION IN COMPARISON WITH CONVENTIONAL INTRAVENOUS SEDATION IN NEUROCRITIC PATIENTS

Phase 1

• Conditions: EUROCRITIC PATIENTS; MedDRA version: 20.0Level: LLTClassification code: 10002182Term: Analgesia Class: 10042613; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: CTIS2024-512077-27-00
• Lead Sponsor: Hospital Universitari De Girona Doctor Josep Trueta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-21
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Patients equal or older than 18 years old, Neurocritical patients (intracranial hemorrhage, severe traumatic brain injury, ischemic or hemorrhagic stroke) who, due to their clinical situation and by decision of the treating physician, require advanced neurological monitoring (ICP catheter, DTC...) and deep sedation Intensive Unit Care admission, Informed consent form signed by a family member/legal representative

Exclusion Criteria

Neurocritical patients with risk of CTEH (by imaging techniques) who do not have ICP catheter monitoring, End-of-life situation or with ICU admission oriented towards donation, Refusal to informed consent by the relative/legal representative of reference., Neurocritical patients monitored with an ICP catheter but with initial values >20 mmHg, Neurocritical patients with decompressive craniectomy monitored with an ICP catheter and with initial values ??>13 mmHg., Severe hypoxemia (pO2<60mmHg) or high FiO2 requirements (>0.6) and/or high PEEP values (>10mmHg)., Patients in shock who require vasoactive support with noradrenaline >0.5mcg/kg/min and/or lactate >2. 5mmol/L., Patients who, upon admission, in the initial neurological evaluation with transcranial Doppler, have a negative Giller Test (loss of cerebral self-regulation)., Patients under 18 years of age., Pregnant or breastfeeding patients., Patients with any contraindication to the administration of isoflurane

Study & Design

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