LIDOCAINE HYDROCHLORIDE MONOHYDRATE for Postoperative critical care

Inclusion criteria

• {"criterion_text":"- Major patient\n- Patient admitted immediately post-operatively in critical care (scheduled or emergency admission, e.g. post-operative exploratory laparotomy, cardiac surgery, heavy orthopaedic surgery such as polytrauma patients, vascular surgery at risk of complications such as open aortic surgery)\n- Anticipated length of stay in critical care ≥ 48h\n- Membership of a social security scheme\n- Informed consent must be obtained and signed by the patient or by a close relative or legal representative or, failing that, the emergency procedure must be followed"}

Exclusion criteria

• {"criterion_text":"- Weight over 100 kg\n- Stage IV/V chronic renal failure, not on dialysis\n- Severe hepatocellular insufficiency at inclusion (Child-Pugh C)\n- Bradycardia < 50 bpm on antiarrhythmic drugs\n- Clinical convulsive seizure at inclusion\n- Predictable inability to answer the questionnaire (cognitive impairment, non-Francophone)\n- Known participation in another interventional research study (RIPH1 or RIPH2)\n- Known situation of deprivation of liberty or legal protection (safeguard of justice, guardianship or curatorship)\n- Hypersensitivity to one of the active substances used for anaesthesia or to one of the excipients\n- Acute porphyria on anamnesis\n- Pregnant or breast-feeding women\n- Patient who has received or will receive peri-medullary analgesia intra-operatively or post-operatively\n- Patient who has received or will receive loco-regional analgesia intra-operatively or post-operatively\n- Severe head injury, open cephalic neurosurgery, interventional neuroradiology\n- Recovered cardiorespiratory arrest\n- Noradrenaline doses > 0.5 μg/kg/min"}

Primary endpoints

• {"endpoint_text":"- Overall score on the IPREA questionnaire (Inconforts of REanimation Patients with 18 items). Within 24 hours before discharge from critical care or, failing that, within 24 hours before the 15th day of hospitalization in critical care. Deceased patients will be considered non-evaluable.","definition_or_measurement_approach":"Overall score on the IPREA 18-item questionnaire collected within 24 hours prior to discharge from critical care or, if not discharged, within 24 hours before day 15 of critical care hospitalisation. Deceased patients are considered non-evaluable."}

Secondary endpoints

• {"endpoint_text":"- Result per item of 8 items of the IPREA score, Within 24 hours before discharge from critical care or, failing that, within 24 hours before the 15th day of hospitalisation in critical care: - Noise - Thirst - Pain - Medical devices (catheters, intubation tubes, etc.) - Sleepiness - Dyspnoea - Anxiety - Depression. Deceased patients will be considered ineligible for evaluation.","definition_or_measurement_approach":"Individual item scores (8 items) of the IPREA questionnaire collected within 24 hours prior to discharge from critical care or, if not discharged, within 24 hours before day 15; deceased patients considered non-evaluable."}
• {"endpoint_text":"- Cumulative opiate consumption over the first 6 post-operative days (in equivalent mg of IV morphine, or µg of Remifentanil or µg of Sufentanil). In the event of death or premature discharge, the criterion will be assessed over the period preceding the death or discharge.","definition_or_measurement_approach":"Total opioid consumption converted to IV morphine equivalent (or specified µg equivalents for Remifentanil/Sufentanil) over postoperative days 0-6; if death or early discharge, assess over available period prior to event."}
• {"endpoint_text":"- The duration of invasive mechanical ventilation in critical care. Until discharge from critical care, including, in the event of transfer, the stay in critical care in the transfer hospital, or, failing that, until day 30. In the event of death or premature discharge, the criterion will be assessed over the period preceding death or discharge.","definition_or_measurement_approach":"Time (duration) of invasive mechanical ventilation measured until discharge from critical care or up to day 30; in transfers or death/discharge, measured over the period preceding the event."}
• {"endpoint_text":"- Re-intubation within 48 hours of extubation (until discharge from critical care, including, in the case of transfer, the stay in critical care at the receiving hospital, or, failing that, until day 30). In the event of death or premature discharge, the criterion will be assessed over the period preceding death or discharge.","definition_or_measurement_approach":"Occurrence of re-intubation within 48 hours after extubation, captured until discharge from critical care or up to day 30; censored at death or premature discharge."}
• {"endpoint_text":"- The duration of sedation. Until discharge from critical care, including, in the event of transfer, the stay in critical care in the transfer hospital, or, failing that, until day 30. In the event of death or premature discharge, the criterion will be assessed over the period preceding death or discharge.","definition_or_measurement_approach":"Duration (time) of sedation recorded until discharge from critical care or up to day 30; if death or discharge, assessed over preceding period."}
• {"endpoint_text":"- The length of stay in critical care, including, in the event of transfer, the stay in critical care in the transfer hospital, over a maximum period of 30 post-operative days. Up to day 30. In the event of death or premature discharge, the criterion will be assessed over the period preceding the death or discharge.","definition_or_measurement_approach":"Critical care length of stay measured up to day 30 postoperatively; in transfers/death/discharge, measured until that event."}
• {"endpoint_text":"- The total length of hospital stay including, in the event of transfer, the stay in the transfer hospital, over a maximum period of 30 post-operative days. Up to day 30. In the event of death or premature discharge, the criterion will be evaluated over the period preceding the death or discharge.","definition_or_measurement_approach":"Total hospital length of stay measured up to 30 days postoperatively; censored at death or discharge as specified."}
• {"endpoint_text":"- Vital status on the 30th postoperative day. J30. In case of premature discharge, the vital status will be censored as of the discharge date.","definition_or_measurement_approach":"Mortality/vital status assessment at postoperative day 30; if early discharge, status censored at discharge date."}
• {"endpoint_text":"- The incidence of care-associated pneumonia (RFE SFAR/SRLF 2017 ‘Care-associated pneumonia’ criteria in appendix). During the stay in critical care, including, in the event of transfer, the stay in critical care in the transfer hospital, up to day 30. In the event of death or premature discharge, the criterion will be assessed over the period preceding the death or discharge.","definition_or_measurement_approach":"Incidence of care-associated pneumonia assessed per RFE SFAR/SRLF 2017 criteria during critical care stay up to day 30; assessed over period prior to death/discharge if applicable."}
• {"endpoint_text":"- The incidence of delirium (measured by CAM ICU). During the stay in critical care, including, in the event of transfer, the stay in critical care in the transfer hospital, up to day 30. In the event of death or premature discharge, the criterion will be assessed over the period preceding the death or discharge.","definition_or_measurement_approach":"Incidence of delirium assessed using CAM-ICU during critical care stay up to day 30; censored at death/discharge as specified."}
• {"endpoint_text":"- The incidence of adverse reactions attributable to lidocaine over the duration of treatment administration and 24 hours after the end of treatment administration. In the event of death or premature discharge, the criterion will be assessed over the period preceding the death or discharge.","definition_or_measurement_approach":"Recording of adverse reactions attributed to lidocaine during infusion and for 24 hours after end of administration; assessed over available period prior to death/discharge."}
• {"endpoint_text":"- Sensitivity analysis : Overall score on the IPREA questionnaire. Data collected within 24 hours prior to discharge from critical care or, failing that, within 24 hours prior to the 15th day of hospitalisation in critical care. Data for deceased patients will be imputed according to the following strategy: - values ​​for patients who died before day 7 will be assigned to the most unfavorable IPREA score (100), - values ​​for patients who died after day 7 will be assigned by multiple imputation.","definition_or_measurement_approach":"Sensitivity analysis of primary IPREA score with imputation strategy for deceased patients: deaths before day 7 assigned worst IPREA score (100); deaths after day 7 handled by multiple imputation. Data collection same timing as primary endpoint."}
• {"endpoint_text":"- Overall score on the IPREA questionnaire. Within 24 hours prior to the 7th day of hospitalization in critical care. Deceased patients will be considered ineligible for evaluation.","definition_or_measurement_approach":"Secondary timepoint assessment of overall IPREA score collected within 24 hours prior to day 7 of critical care hospitalisation; deceased patients non-evaluable."}

France

Earliest CTIS Part Ii Submission Date

29-04-2025

Latest Decision Or Authorization Date

10-02-2026

Processing Time Days

287

Number Of Sites

13

Number Of Participants

246

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Rennes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France