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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512077-27-00
Acronym
NEURO-CONDA
Enrollment
24
Registered
2024-03-20
Start date
2024-04-04
Completion date
Unknown
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NEUROCRITIC PATIENTS

Brief summary

Sedation variables: RASS scale, Bispectral Index (BIS), Delta BIS index, required doses of intravenous or inhalation sedation during the study period, Placement of the Sedaconda device: in the mouth or on the inspiratory branch, recording of the ISOef value (expiratory fraction gas) during the study period. The upper permitted ISOef limit will be set at 1%. Respiratory, hemodynamic variables, neuromomitorization and infectious status

Detailed description

Adverse effects observed throughout the study. • Awakening time and presence/absence of delirium in this patient awakening process. • Alteration of liver function throughout the study. • Alteration of kidney function throughout the study. • Days spent in ICU. • Days spent in the hospital. • Mortality in ICU. • Hospital mortality, Data based on analgesia will be collected: Values ​​obtained with NOL (Annex 9). The value indicates the degree of nociception and the required doses of intravenous opioids during the study period.

Interventions

DRUGPROPOFOL
DRUGISOFLURANE
DRUGMIDAZOLAM

Sponsors

Hospital Universitari De Girona Doctor Josep Trueta
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Sedation variables: RASS scale, Bispectral Index (BIS), Delta BIS index, required doses of intravenous or inhalation sedation during the study period, Placement of the Sedaconda device: in the mouth or on the inspiratory branch, recording of the ISOef value (expiratory fraction gas) during the study period. The upper permitted ISOef limit will be set at 1%. Respiratory, hemodynamic variables, neuromomitorization and infectious status

Secondary

MeasureTime frame
Adverse effects observed throughout the study. • Awakening time and presence/absence of delirium in this patient awakening process. • Alteration of liver function throughout the study. • Alteration of kidney function throughout the study. • Days spent in ICU. • Days spent in the hospital. • Mortality in ICU. • Hospital mortality, Data based on analgesia will be collected: Values ​​obtained with NOL (Annex 9). The value indicates the degree of nociception and the required doses of intravenous opioids during the study period.

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026