Evaluation of the Efficacy of Inhalatory Sedation in Comparison with Conventional Intravenous Sedation in Neurocritic Patients

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital Universitari De Girona Doctor Josep Trueta

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

4 Apr 2024 → ongoing

Decision date (initial)

2024-03-20

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

1.To evaluate the efficacy and safety of using inhalation sedation with isoflurane in neurocritical patients versus conventional intravenous sedation.
2.NOL monitoring is an effective tool to evaluate the analgesic status of deeply sedated patients.

Secondary objectives 5

1. Record the doses required for the goal of deep sedation, both intravenous sedation and isoflurane.
2. Monitor respiratory and hemodynamic parameters as well as the need for vasoactive support before and after the start of sedation therapy. Check if there are statistically significant differences in both groups of patients
3. Record the NOL values ​​as well as the required doses of opioids in patients from both study groups.
4. Determine the patients' awakening time (evolution through numerical monitoring with the BIS system), as well as the presence of delirium and compare these times and incidence of delirium in both groups
5. Record possible adverse effects in both therapies

Conditions and MedDRA coding

NEUROCRITIC PATIENTS

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patients equal or older than 18 years old
2. 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
3. Informed consent form signed by a family member/legal representative

Exclusion criteria 11

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 2

1. 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
2. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Universitari De Girona Doctor Josep Trueta

Sponsor organisation

Hospital Universitari De Girona Doctor Josep Trueta

Address

Avinguda De Franca S/n

City

Girona

Postcode

17007

Country

Spain

Scientific contact point

Organisation

Hospital Universitari De Girona Doctor Josep Trueta

Contact name

Dra Cristina Murcia

Public contact point

Organisation

Hospital Universitari De Girona Doctor Josep Trueta

Contact name

Dra Cristina Murcia

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

2 submissions — initial application plus substantial / non-substantial modifications