Sedation Complication

9

Review clinical trials related to Sedation Complication. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome

This study will investigate how different types of routine sedation may affect patient's breathing whilst on a ventilator in the Intensive Care Unit (ICU). There are different approaches to sedation which may have advantages and disadvantages. During the study patients will receive both intravenous and inhaled volatile sedation (similar to anaesthetic 'gases' used for general anaesthesia) and the drive to breath, breathing efforts and function of the lung will be assessed.

Participants needed: 20
Trial details
Phase: Phase 2, Phase 3Age: 17+Biological sex: AllType: InterventionalSponsor: Guy's and St Thomas' NHS Foundation TrustUpdated: Jun 4, 2026Locations: 1
Eligibility criteria

Adult patients admitted to the Intensive Care Unit (ICU) [+7]

Personal or family history of malignant hyperpyrexia [+5]

Status: Recruiting

A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy

The goal of this prospective, randomized, controlled study is to compare remimazolam besilat/sufentanyl and propofol/sufentanyl in patients during colonoscopic polypectomies procedures. Patients undergoing colonoscopic polypectomies in procedural sedation using remimazolam besylate/sufentanyl are circulatory and respiratory as or more stable when compared with propofol/sufentanyl sedation.

Participants needed: 90
Trial details
Phase: Phase 4Age: 18-60Biological sex: AllType: InterventionalSponsor: Clinical Hospital Centre ZagrebUpdated: Mar 6, 2026Locations: 1
Eligibility criteria

Patients both male and female [+6]

Patients aged >60 years [+18]

Status: Recruiting

Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal Intensive Care

This study aims to describe a dose-effect relationship of morphine alone and morphine and midazolam administered as continuous infusion in neonates hospitalized in Neonatal intensive care unit and undergoing mechanical ventilation, through PKPD modelling.

Participants needed: 180
Trial details
Age: 20-45Biological sex: AllType: InterventionalSponsor: Centre Hospitalier Intercommunal CreteilUpdated: Nov 17, 2025Locations: 5
Eligibility criteria

Neonates < 45 weeks of corrected gestational age [+4]

Current weight < 600g [+5]

Status: Recruiting

Goal-Directed Sedation in Mechanically Ventilated Infants and Children

Ventilated pediatric patients are frequently over-sedated and the majority suffer from delirium, a form of acute brain dysfunction that is an independent predictor of increased risk of dying, length of stay, and costs. Universally prescribed sedative medications-the GABA-ergic benzodiazepines-worsen this brain organ dysfunction and independently prolong duration of ventilation and ICU stay, and the available alternative sedation regimen using dexmedetomidine, an alpha-2 agonist, has been shown to be superior to benzodiazepines in adults, and may mechanistically impact outcomes through positive effects on innate immunity, bacterial clearance, apoptosis, cognition and delirium. The mini-MENDS trial will compare dexmedetomidine and midazolam, and determine the best sedative medication to reduce delirium and improve duration of ventilation, and functional, psychiatric, and cognitive recovery in our most vulnerable patients-survivors of pediatric critical illness.

Participants needed: 372
Trial details
Phase: Phase 3Age: 44-11Biological sex: AllType: InterventionalSponsor: Vanderbilt University Medical CenterUpdated: Sep 29, 2025Locations: 1
Eligibility criteria

Patients will be eligible for enrollment if they are 1) aged 44 weeks post-menst...

Receiving continuous sedation for > 72 hours prior to screening. [+17]

Status: Recruiting

multipaRameter mOnitoring systeM for sedAtion iNThe ICu

The administration of sedation in Intensive Care Units (ICU) is a vital and complex task, essential for the well-being of critically ill patients. Proper dosing is crucial, as both under-dosing and overdosing have adverse consequences for patients, including risks such as accidental extubation, ventilator disconnections, delirium, prolonged ventilation, ICU stays, and even increased mortality. Monitoring sedation levels is essential to maintain a balance in sedative administration. Clinical scales (RASS/SAS) are currently used as the reference method, but they have limitations. These scales may be inadequate when the patient is unresponsive or when neuromuscular blockers are used. An alternative is electroencephalography (EEG)-based monitors, though they also have limitations in accurately representing the level of hypnosis. The proposal is to develop an advanced multiparameter system called ROMANTIC, which utilizes machine learning algorithms to monitor sedation status continuously. The aim is for this system to surpass current techniques and provide a more accurate determination of sedation levels. ROMANTIC would incorporate a variety of variables, demographic, pharmacological, hemodynamic, respiratory, and EEG data, to predict sedation status in three categories: under-dosing, appropriate dosing, and overdosing. With ROMANTIC, clinical staff (users) are expected to be able to determine sedation levels more quickly and accurately, reducing patients' wake-up times and possibly decreasing the incidence of delirium. In the long term, this could result in fewer ICU bed days, less time on mechanical ventilation, cost savings, and reduced complications. At the end of the project, the goal is to have a prototype model or software that allows non-specialized staff (users) to quickly determine sedation levels in the ICU. This machine learning-based model targets hospitals with ICUs and mechanical ventilation to offer more efficient and cost-effective clinical care. ROMANTIC seeks to innovate in sedation monitoring, providing a more advanced and precise tool for the care of critically ill patients (beneficiaries) in the ICU.

Participants needed: 80
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Pontificia Universidad Catolica de ChileUpdated: Jun 8, 2025Locations: 2Duration: 2 Weeks
Eligibility criteria

Patients admitted to adult critical care units [+3]

Patients with neurological pathology as the cause of mechanical ventilation (inc... [+7]

Status: Recruiting

Validation of a Processed EEG Device for Monitoring Sedation in PICU

The goal of this prospective observational study is to validate pEEG as a monitoring tool for the analgosedation level in mechanically-ventilated critically ill children, receiving or not-receiving NMBAs. The main question aims to answer is to measure the strength of agreement between pEEG score and Comfort Behavioural Scale (CBS) (goal standard). Participants will be monitored with pEEG and CBS evaluated during PICU admission. paralysis holiday) by a specialized PICU nurse and by a critical-care expert physician, blinded to each other.

Participants needed: 150
Trial details
Age: 1-18Biological sex: FemaleType: ObservationalSponsor: Azienda Ospedaliera di PadovaUpdated: Jan 28, 2025Locations: 1
Eligibility criteria

skin lesions [+1]

Status: Recruiting

Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX in ICU Patients

Sedation and analgesia are fundamental tools for managing critical patients who require mechanical ventilation. However, recent scientific literature highlights that excessive sedation in these patients can increase the duration of mechanical ventilation and extend the overall length of stay in intensive care, as well as expose them to a higher risk of hypotension, venous thrombosis, and nosocomial pneumonia. The titration of sedation and analgesia in intensive care, on the other hand, is currently based primarily on clinical parameters (such as the onset of delirium, asynchronies with the ventilator, for example), which can lead to treatments not proportionate to the patient's needs. The present study aims to evaluate the application, in an intensive care setting, of the Conox® system, a device already widely used in monitoring the anesthetic plan in the operating room. This tool would allow, through the processing of an EEG trace, the assessment of the level of sedation (qCON) and the probable algic response (qNOX), thus providing valuable information for the fine-tuning of the analgo-sedative plan.

Participants needed: 174
Trial details
Age: 18-90Biological sex: AllType: InterventionalSponsor: Università degli Studi di FerraraUpdated: Jan 10, 2025Locations: 2
Eligibility criteria

Not listed

Status: Not yet recruiting

Position Intervention to Reduce Hypoxemia in Sedation Patients

Hypoxemia was defined as an SpO2 of \< 90% for any duration. Failure to treat promptly can lead to hypoxemia, which may increase the risks of arrhythmia, nausea and vomiting, and cognitive dysfunction. Studies have shown that body position has a direct impact on respiratory function. In special environments, including outside the operating room where emergency airway management for critically ill and injured patients is needed, or in areas with limited medical resources like remote areas, adopting simple interventions by changing position to maintain patients' respiratory function can be more economical, convenient and safe.

Participants needed: 1,752
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Zhejiang UniversityUpdated: Jun 14, 2024Locations: 1
Eligibility criteria

Patients with 18 years or older [+3]

Preexisting bradycardia (heart rate <50 beats/min), hypotension (systolic blood... [+7]

Status: Recruiting

Safe Brain Initiative, Operationalizing Precision Anaesthesia

Perioperatively, patients experience an unnecessarily high level of side effects associated with their treatment. These side effects include nausea, severe pain, anxiety, and stress. Moreover, many patients develop postoperative delirium (POD) and neurocognitive dysfunctions, often resulting in long-term cognitive impairment, decreased quality of life, and increased mortality. However, physicians, nurses and their institutions do not receive structured feedback regarding these aspects of each patient's well-being. They may therefore be unable to engage in the essential cause-and-effect learning necessary to evaluate and consecutively reduce such side effects. Effective guidelines conform prevention is the proven key to shielding our patients from adverse Outcomes. The Safe Brain Initiative's high-quality routine data-for-action is a sword and accelerator for moving towards patient-centred, precision care. Thus, establishing a foundation for value-based and patient-centred healthcare development. However, a turnkey real-world solution is challenging to develop and implement and requires substantial resources. As a result, such solutions are usually beyond the scope of a single institution. The SBI platform provides high-quality, real-world data to bridge this gap. It allows monitoring and in-depth analysis of cause and effect in the day-to-day routine of individuals, departments, and institutions. The SBI's approach is continuously improved and updated. An organization called the SBI Global Society oversees the quality and precision of science through experts in the field. At SBI Hospitals and Flagship centres, Masterclasses are conducted and can be attended alongside clinical immersions. SBI Solutions manages, develops, and provides technical and service support for the Safe Brain Initiative. Its service guarantees the professional and GDPR conform management of data handling and storage as well as the user-friendly functionality of the SBI-Dashboard solutions.

Participants needed: 15,000
Trial details
Age: 18-100Biological sex: AllType: ObservationalSponsor: University of Southern DenmarkUpdated: Jun 7, 2024Locations: 1Duration: 5 Years
Eligibility criteria

Not listed