Clinical trial • Phase IV • Other
NEFOPAM HYDROCHLORIDE for Intubation|Mechanical ventilation
Phase IV trial of NEFOPAM HYDROCHLORIDE for Intubation|Mechanical ventilation.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Intubation|Mechanical ventilation
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 19-09-2024
- First CTIS Authorization Date
- 17-10-2024
Trial design
Randomised, interventional strategy (opioid free): fixed combination of nefopam and tramadol initiated at daily doses of 400mg and 120mg respectively; initial dose of 50mg tramadol and 20mg nefopam ivl over 30 minutes; analgesia re-evaluated every 30 minutes for first 2 hours then every 2 hours. comparator (conventional strategy): combination of paracetamol and remifentanil with remifentanil doses adapted according to tiered administration based on bps and theoretical ideal weight; remifentanil doses adjusted in stages until bps ≤4; analgesia reassessed every 30 minutes until adaptation complete, then every 2 hours. placebo used: 0.9% sodium chloride (placebo).-controlled Phase IV trial across 1 site in France.
- Randomised
- Yes
- Comparator
- Interventional strategy (opioid free): fixed combination of nefopam and tramadol initiated at daily doses of 400mg and 120mg respectively; initial dose of 50mg tramadol and 20mg nefopam IVL over 30 minutes; analgesia re-evaluated every 30 minutes for first 2 hours then every 2 hours. Comparator (Conventional strategy): combination of paracetamol and remifentanil with remifentanil doses adapted according to tiered administration based on BPS and theoretical ideal weight; remifentanil doses adjusted in stages until BPS ≤4; analgesia reassessed every 30 minutes until adaptation complete, then every 2 hours. Placebo used: 0.9% sodium chloride (placebo).
- Target Sample Size
- 50
- Trial Duration For Participant
- 90
Eligibility
Recruits 50 Vulnerable population selected. Consent may be provided as: "Informed consent signed by the patient or his trusted person, legal representative, family member, curator or tutor, or emergency consent procedure"; translated subject information and ICF documents exist for patient and proche..
- Pregnancy Exclusion
- Parturient or breast-feeding patient
- Vulnerable Population
- Vulnerable population selected. Consent may be provided as: "Informed consent signed by the patient or his trusted person, legal representative, family member, curator or tutor, or emergency consent procedure"; translated subject information and ICF documents exist for patient and proche.
Inclusion criteria
- {"criterion_text":"- Patient hospitalized in ICU and requiring sedation-analgesia for mechanical ventilation"}
- {"criterion_text":"- Patient undergoing mechanical ventilation for more than 2 hours and less than 24 hours."}
- {"criterion_text":"- Informed consent signed by the patient or his trusted person, legal representative, family member, curator or tutor, or emergency consent procedure"}
- {"criterion_text":"- Patient affiliated to the French Government Public Health Insurance"}
- {"criterion_text":"- Patient over 18 years old"}
Exclusion criteria
- {"criterion_text":"- Patient already involved in a trial that might influence our primary endpoint"}
- {"criterion_text":"- Patient in exclusion-period determined by another trial or study"}
- {"criterion_text":"- Patient who is likely to be requiring less than 48 hours of mechanical ventilation"}
- {"criterion_text":"- Patient with contraindication or allergies to at least one of the following medication : paracetamol, nefopam, tramadol, ketamine, remifentanil"}
- {"criterion_text":"- Patient with hepatic insufficiency (defined as PT < 50%)"}
- {"criterion_text":"- Parturient or breast-feeding patient"}
- {"criterion_text":"- Patient suffering from moderate to severe Acute Respiratory Distress Syndrome (ARDS), with decreased PaO2/FiO2 ratio under 150mmHg after respiratory optimization (courant volume 6mL/kg and PEEP > 5mbar)"}
- {"criterion_text":"- Patient requiring curare treatment"}
- {"criterion_text":"- Patient requiring ICU after undergoing major surgery (laparotomy or thoracotomy)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- daily consumption of remifentanil between the 24th hour and the 48th hour after randomisation of patients admitted to the ICU and requiring at least 72 hours of mechanical ventilation","definition_or_measurement_approach":"Measured as daily remifentanil consumption between 24 and 48 hours post-randomization (as stated in endpoint description)."}
Secondary endpoints
- {"endpoint_text":"- Cumulative dose of remifentanil","definition_or_measurement_approach":"Measured as cumulative remifentanil dose over the observation period."}
- {"endpoint_text":"- Number of lived days free of remifentanil","definition_or_measurement_approach":"Count of alive days without remifentanil exposure within the observation period."}
- {"endpoint_text":"- Daily consumption of sedative drugs from inclusion to D28","definition_or_measurement_approach":"Measured as daily dose/consumption of sedative medications from inclusion through day 28."}
- {"endpoint_text":"- Number of live days free of mechanical ventilation","definition_or_measurement_approach":"Count of days the patient is alive and free from mechanical ventilation during the follow-up period."}
- {"endpoint_text":"- SOFA Score (Sepsis-related Organ Failure Assessment)","definition_or_measurement_approach":"Measured using the SOFA scoring system; changes/trends to be recorded."}
- {"endpoint_text":"- Daily fuid intake in milliliter","definition_or_measurement_approach":"Measured as daily fluid intake (milliliters) related to analgesia."}
- {"endpoint_text":"- CAM ICU test","definition_or_measurement_approach":"Assessment of delirium using the CAM-ICU test."}
- {"endpoint_text":"- Presence of one or more events of special interest or expected adverse events: constipation, bradycardia, bladder globe, nausea, vomiting, liver disturbance, serotonin syndrome","definition_or_measurement_approach":"Recorded occurrence of listed adverse events of interest during follow-up."}
- {"endpoint_text":"- Presence of pneumonia associated with mechanical ventilation","definition_or_measurement_approach":"Diagnosis/recording of ventilator-associated pneumonia during follow-up."}
- {"endpoint_text":"- Extubation failure and cause (reintubation within 48 hours of first extubation)","definition_or_measurement_approach":"Extubation failure defined as reintubation within 48 hours of the first extubation."}
- {"endpoint_text":"- Length of stay in the intensive care unit and in the hospital","definition_or_measurement_approach":"Measured as duration (days) of ICU and overall hospital stay."}
- {"endpoint_text":"- Vital status at day 28 and day 90","definition_or_measurement_approach":"Recorded survival status at day 28 and day 90 post-inclusion."}
- {"endpoint_text":"- Opioid use at D90","definition_or_measurement_approach":"Assessment of opioid consumption/use at day 90."}
Recruitment
- Planned Sample Size
- 50
- Recruitment Window Months
- 43
- Consent Approach
- Informed consent may be signed by the patient or by the patient's trusted person, legal representative, family member, curator or tutor; emergency consent procedure is allowed. Subject information and ICF documents are available for patient and proche (French language documents present). Vulnerable population selection noted in trial record.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 50
France
- Earliest CTIS Part Ii Submission Date
- 26-09-2024
- Latest Decision Or Authorization Date
- 19-11-2025
- Processing Time Days
- 419
- Number Of Sites
- 1
- Number Of Participants
- 50
Sites
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- +33466683050
- Principal Investigator Name
- Rémy WIDEHEM
- Principal Investigator Email
- remy.widehem@chu-nimes.fr
- Contact Person Name
- Rémy WIDEHEM
- Contact Person Email
- remy.widehem@chu-nimes.fr
- Number Of Participants
- 50
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire De Nimes
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- NEFOPAM VIATRIS 20 mg/2 ml, solution injectable
- Active Substance
- NEFOPAM HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised
- Starting Dose
- Initial dose of 20mg nefopam IVL over 30 minutes (per arm description)
- Dose Levels
- Protocol daily dose described as 400 mg (per arm description); product max daily dose listed as 120 mg in product dictionary
- Frequency
- Daily (as per protocol experimental schedule)
- Maximum Dose
- 120 mg (product maxDailyDoseAmount) / protocol describes daily 400 mg
- Investigational Product Name
- TRAMADOL ARROW 100 mg/2 mL, solution injectable/pour perfusion
- Active Substance
- TRAMADOL HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised
- Starting Dose
- Initial dose of 50mg tramadol IVL over 30 minutes (per arm description)
- Dose Levels
- Protocol daily dose described as 120 mg (per arm description); product max daily dose listed as 450 mg
- Frequency
- Daily (as per protocol experimental schedule)
- Maximum Dose
- 450 mg (product maxDailyDoseAmount)
- Investigational Product Name
- PARACETAMOL B BRAUN 10 mg/ml, solution pour perfusion
- Active Substance
- PARACETAMOL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised
- Dose Levels
- Product max daily dose 3 g (product dictionary)
- Frequency
- As per conventional strategy dosing schedule
- Maximum Dose
- 3 g (product maxDailyDoseAmount)
- Investigational Product Name
- ULTIVA 5 mg, poudre pour solution injectable ou pour perfusion
- Active Substance
- REMIFENTANIL HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous infusion
- Authorisation Status
- Authorised
- Dose Levels
- Product lists dosing in mg/kg/h; product maxDailyDoseAmount 0.03 mg/kg/h
- Frequency
- Continuous infusion adjusted in stages per protocol
- Maximum Dose
- 0.03 mg/kg/h (product maxDailyDoseAmount)
- Investigational Product Name
- KETAMINE RENAUDIN 50 mg/ml, solution injectable
- Active Substance
- KETAMINE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised
- Dose Levels
- Product maxDailyDoseAmount 0.15 mg/kg/h (product dictionary shows doseUom mg/kg/h and maxDailyDoseAmount 0.15)
- Maximum Dose
- 0.15 mg/kg/h (product maxDailyDoseAmount)
- Investigational Product Name
- CHLORURE DE SODIUM 0,9 % AGUETTANT, solution pour perfusion
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised
- Dose Levels
- Used as placebo; product maxDailyDoseAmount 600 ml
- Frequency
- As per blinded administration schedule
- Maximum Dose
- 600 ml/day (product maxDailyDoseAmount)
- Combination Treatment
- Yes
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