Clinical trial • Phase IV • Other
PROPOFOL for Neurocritical illness
Phase IV trial of PROPOFOL for Neurocritical illness. Isoflurane (Comparator) — route: INHALATION; max total dose amount: 15 (dose unit: Other)-controlled.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Neurocritical illness
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 25-03-2025
- First CTIS Authorization Date
- 04-07-2025
Trial design
Isoflurane (Comparator) — route: INHALATION; max total dose amount: 15 (dose unit: Other)-controlled Phase IV trial across 1 site in Spain.
- Comparator
- Isoflurane (Comparator) — route: INHALATION; max total dose amount: 15 (dose unit: Other)
- Target Sample Size
- 144
- Trial Duration For Participant
- 3
Eligibility
Recruits 144 Vulnerable population not selected. Consent may be provided by the patient, a family member, or a legal representative ("Signed informed consent from the patient, family member, or legal representative.")..
- Vulnerable Population
- Vulnerable population not selected. Consent may be provided by the patient, a family member, or a legal representative ("Signed informed consent from the patient, family member, or legal representative.").
Inclusion criteria
- {"criterion_text":"- Patients of both sexes aged ≥ 18 years"}
- {"criterion_text":"- Indication for deep sedation (RASS < -4)"}
- {"criterion_text":"- Need for neuromuscular relaxation. The use of neuromuscular blocking agents (NMBAs) in deep sedation in the ICU is indicated in situations requiring complete muscle paralysis to optimize mechanical ventilation and reduce oxygen consumption, such as ARDS, increased intracranial pressure (ICP), and status epilepticus. Prolonged use (>72h) should be avoided to prevent ICU-acquired weakness. In our unit, we primarily use cisatracurium (a non-depolarizing NMBA) as a continuous infusion at 1-4 mcg/kg/min and rocuronium (a non-depolarizing NMBA) as a bolus at 0.6-1.2 mg/kg or a continuous infusion at 4-12 mcg/kg/min. We monitor its administration using Train-of-Four (TOF) to prevent overdosing"}
- {"criterion_text":"- Expected ICU stay of at least 72 hours."}
- {"criterion_text":"- Signed informed consent from the patient, family member, or legal representative."}
Exclusion criteria
- {"criterion_text":"- End-of-life situation or poor vital prognosis"}
- {"criterion_text":"- Physical impossibility of monitoring with NOL."}
- {"criterion_text":"- Contraindications to NOL or sedation with isoflurane"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Sedation variables:Respiratory, hemodynamic, neuromonitoring, and infectious status variables.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Observed Adverse Effects Throughout the Study:- Time to awakening and presence/absence of delirium during the patient's awakening process. - ICU length of stay. - Hospital length of stay. - ICU mortality. - Hospital mortality- Opiodis abstincence","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 144
- Recruitment Window Months
- 23
- Consent Approach
- Signed informed consent from the patient, family member, or legal representative. Subject information and informed consent form (adult) documents available in Spanish and Catalan (documents: L1_SIS and ICF adults SPANISH; L1_SIS and ICF adults CATALAN; adult ICF versions available). No assent process for minors indicated (trial includes adults ≥ 18 years).
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 144
Spain
- Earliest CTIS Part Ii Submission Date
- 19-05-2025
- Latest Decision Or Authorization Date
- 04-07-2025
- Processing Time Days
- 46
- Number Of Sites
- 1
- Number Of Participants
- 144
Sites
- Site Name
- Hospital Universitari De Girona Doctor Josep Trueta
- Department Name
- Unidad de Medicina Intensiva
- Principal Investigator Name
- Marina Vila
- Principal Investigator Email
- m.vilarivas@gmail.com
- Contact Person Name
- Marina Vila
- Contact Person Email
- m.vilarivas@gmail.com
- Number Of Participants
- 144
Sponsor
Primary sponsor
- Full Name
- Hospital Universitari De Girona Doctor Josep Trueta
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- PROPOFOL
- Active Substance
- PROPOFOL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- INTRAVENOUS ADMINISTRATION
- Authorisation Status
- prodAuthStatus: 2; marketingAuthNumber: -
- Maximum Dose
- 4.5 mg/kg/h
- Investigational Product Name
- ISOFLURANE
- Active Substance
- ISOFLURANE
- Modality
- Small molecule
- Routes Of Administration
- INHALATION
- Route
- INHALATION
- Authorisation Status
- prodAuthStatus: 2; marketingAuthNumber: -
- Maximum Dose
- 15 (dose unit: Other)
- Investigational Product Name
- MIDAZOLAM
- Active Substance
- DOBUTAMINE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- INTRAVENOUS ADMINISTRATION
- Authorisation Status
- prodAuthStatus: 2; marketingAuthNumber: -
- Maximum Dose
- 0.25 mg/kg/h
Related trials
Other published trials that may interest you.