Clinical Research Directory

Remimazolam Combined With Oliceridine for Sedation in Elderly Patients Undergoing Gastrointestinal Endoscopy

This study aims to evaluate the sedative efficacy and safety of remimazolam combined with oliceridine in elderly patients undergoing painless gastrointestinal endoscopy. Elderly patients often face higher risks of respiratory and hemodynamic depression during clinical sedation. This trial will investigate whether the combination of remimazolam and oliceridine can provide stable sedation, maintain stable vital signs, and reduce the incidence of adverse events such as hypoxemia and postoperative cognitive fluctuation in this vulnerable population.

High-Flow Nasal Oxygyen Therapy During Sedated Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration(EBUS-TBNA)

This study aims to evaluate the effects of high-flow nasal oxygen therapy on respiratory complications, blood gas parameters, and post-procedural recovery in patients undergoing sedated endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Participants will be assigned to receive either high-flow nasal oxygen therapy or conventional oxygen therapy during the procedure. The incidence of respiratory complications, blood gas changes, and recovery outcomes will be compared between the two groups.

Dexametedomidine Ketamine Infusion Versus Dexametedomidine Propofol Infusion in Non-compliant Agitated Patients on Continuous Positive Airway Pressure (CPAP) Mask Ventilation in the Intensive Care Unit

Continuous positive airway pressure (CPAP) is a type of positive airway pressure, where the air flow is introduced into the airways to maintain a continuous pressure to constantly stent the airways open, in people who are breathing spontaneously. The application of CPAP maintains positive end expiratory pressure (PEEP), can decrease atelectasis, increases the surface area of the alveolus, improves V/Q matching, and hence, improves oxygenation. Analgesia and sedation are essential components of care for critically ill patients, helping to relieve pain and anxiety, facilitate invasive procedures, reduce physiological stress and oxygen demand, and improve patient-ventilator synchrony. However, sedation practices vary considerably due to differences in institutional protocols, clinician preferences, and patient characteristics. Both inadequate and excessive sedation can adversely affect outcomes: untreated pain and agitation increase the sympathetic stress response, while oversedation is associated with prolonged mechanical ventilation, longer intensive care unit (ICU) stays, and a higher incidence of delirium and coma. Combinations of propofol, benzodiazepines and opioids are frequently used for sedation. Opioids are usually added in painful procedures because benzodiazepines and propofol do not have any analgesic effect. However, opioid administration can lead to excessive sedation and some side effects. Propofol (non-opioid, non-barbiturate, short-acting anesthetic agent) is popular in sedation because of its rapid induction and recovery times. However, its side effects, particularly cardiopulmonary depression, apnea and hypoventilation, have attracted attention to the search for alternatives. Ketamine can be an alternative to opioids because it provides good analgesia even at low doses, sparing the respiratory and cardiovascular adverse effects of opioids. Unfortunately, its side effects (increased salivation, nausea, nightmares, delirium, and excitation) do not make it favorable as a single agent. The past few years have carried increased interest in dexmedetomidine (a selective alpha-2 receptor agonist) in both anesthesia and intensive care. This alpha-2 receptor agonist has been used as the drug of choice for sedation in pediatric patients because of its lack of respiratory depressive effects, adequate sedative and analgesic action, and favorable antiarrhythmic effects. Furthermore, minimizing benzodiazepine use and preferentially using propofol or dexmedetomidine to achieve appropriate sedation levels are associated with improved clinical outcomes.

A Prospective Multicenter Registry Study of Sedation and Analgesia in Critically Ill Patients

Sedation and analgesia are essential components of comprehensive care for intensive care unit (ICU) patients, particularly those receiving invasive mechanical ventilation, undergoing invasive procedures, or experiencing pain, anxiety, agitation, and patient-ventilator asynchrony. Appropriate sedation and analgesia can alleviate pain and discomfort, improve tolerance of mechanical ventilation and other life-support therapies, and help maintain treatment safety. In recent years, the paradigm of ICU sedation has gradually shifted from traditional deep sedation toward management strategies centered on analgesia-first, light sedation, and individualized sedation targets. Clinical practice emphasizes regular assessment of pain, depth of sedation, and delirium, with dynamic adjustment of sedation and analgesia regimens according to the patient's condition. The Richmond Agitation-Sedation Scale (RASS) has been widely used to assess sedation depth in the ICU, while the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is commonly used for delirium screening in critically ill patients. However, in real-world clinical practice, sedation requirements vary considerably among patients, and the choice of sedative agents is still influenced by multiple factors, including patient age, underlying diseases, circulatory status, organ function, mechanical ventilation requirements, and physicians' prescribing habits. Currently commonly used sedatives include propofol, dexmedetomidine, and midazolam, as well as newer intravenous sedatives that have been gradually introduced into clinical practice in recent years, such as remimazolam and ciprofol. These agents may differ in sedative efficacy, hemodynamic stability, speed of emergence, delirium risk, and duration of mechanical ventilation; however, direct comparative evidence among them in real-world ICU patients remains limited. Moreover, sedation management is not merely a matter of drug selection. Depth and duration of sedation, dose adjustment, rescue sedation, combination therapy, and analgesic exposure may all affect patients' neurological status and clinical outcomes. Excessive or prolonged sedation may lead to delayed emergence, prolonged mechanical ventilation, coma, and delirium, whereas inadequate sedation may increase the risks of agitation, patient-ventilator asynchrony, self-extubation, and unplanned device removal. Therefore, it is necessary to establish a standardized, prospective clinical database for ICU sedation and analgesia that systematically records patient baseline characteristics, disease severity, use of sedative and analgesic agents, sedation depth, pain, delirium, organ support, and clinical outcomes, and to evaluate the effectiveness and safety of different sedation and analgesia strategies based on real-world clinical practice. This study aims to establish a prospective, multicenter registry cohort of sedation and analgesia in critically ill patients. Without interfering with clinicians' therapeutic decisions, it will systematically evaluate the characteristics of ICU sedation and analgesia practice and their association with patient clinical outcomes, and provide a high-quality data foundation for subsequent comparative effectiveness research on different sedative agents and sedation strategies, target trial emulation (TTE), and individualized sedation strategy research.

The Impact of Long-term High-risk Drinking on the Effective Dose of Osselidin

this study aims to investigate the effect of chronic high-risk alcohol consumption on the effective dose of oliceridine combined with propofol for painless gastroscopy, so as to provide a reference for rational clinical medication.

Efficacy and Safety of Nasopharyngeal Tube During Sedation

The goal of this randomized controlled study is to determine whether nasopharyngeal tube oxygenation could increase the fraction of inspired oxygen compared with standard oxygen during a sedated procedure with spontaneous breathing. The main question it aims to answer is: • Does nasopharyngeal tube oxygenation deliver higher fraction of inspired oxygen without increasing adverse events, compared with regular nasal cannula during sedation? Researchers will compare nasopharyngeal tube to regular nasal cannula to see if nasopharyngeal tube oxygenation deliver higher fraction of inspired oxygen. Participants will: • Receive regular nasal cannula or nasopharyngeal tube

Neurosteer Bedside Monitoring System

The purpose of this study is to evaluate the clinical utility of Neurosteer's brain monitoring platform for monitoring delirium, sedation, and agitation in intubated and sedated ICU patients. The research team will be conducting a single-site study. The research team will enroll 100 patients admitted to the NSICU. 50 of these patients will have Acute Neurological Injuries (ANI) and the other 50 will not have an ANI. All enrolled patients will receive the intervention, the Neurosteer brain monitoring device. The study intervention consists of the use of Neurosteer's innovative single-channel EEG monitoring device to determine if there is a good correlation and agreement between their signals/parameters to RASS, CAM-ICU, and continuous EEG monitoring readings. The Neurosteer device will be attached to their forehead and readings will be collected for the duration of their NSICU stay. The research team will adapt the current physical methods of detecting the depth of anesthesia i.e. through the Richmond Agitation-Sedation Scale (RASS) \& CAM-ICU, to auditory stimulation, which will be delivered through earphones with no physical contact, with the aim of achieving a high correlation between the methods. RASS and CAM-ICU will be collected hourly as standard of care and Neurosteer auditory stimulation will be done 3-4 times a day to coincide with RASS and 1-2 times a day to coincide with CAM-ICU. The research team will correlate collected hourly RASS and CAM-ICU assessments with Neurosteer derived signals and parameters.

Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Undergoing ERCP

Background: Endoscopic retrograde cholangiopancreatography (ERCP) is a key technique for treating pancreatobiliary diseases in the elderly. However, traditional sedative and analgesic regimens (e.g., sufentanil combined with propofol) are associated with a high incidence of respiratory depression, postoperative nausea and vomiting (PONV), and delayed recovery in elderly patients. Anricofen is a novel peripherally selective κ-opioid receptor agonist that provides analgesia with minimal central respiratory depression. Ciprofol is a new sedative agent characterized by rapid onset and quick recovery. The combination of these two drugs may offer a safer sedation and analgesia regimen for elderly patients undergoing ERCP. Objective: To evaluate the efficacy and safety of anricofen combined with ciprofol for deep sedation in elderly patients undergoing ERCP, compared with the traditional regimen (sufentanil combined with ciprofol). Methods: This is a single-center, randomized, double-blind, controlled trial. A total of 141 elderly patients aged 60-90 years with ASA physical status II-III scheduled for elective ERCP will be enrolled and randomly assigned in a 1:1:1 ratio to three groups: Anricofen 0.3 μg/kg + Ciprofol 1.0 mg/kg, Anricofen 0.5 μg/kg + Ciprofol 1.0 mg/kg, or Sufentanil 0.1 μg/kg + Ciprofol 1.0 mg/kg. The primary efficacy endpoint is the intraoperative pain control success rate (proportion of time with Behavioral Pain Scale \[BPS\] score ≤3 ≥90%). The primary safety endpoint is the incidence of respiratory depression (respiratory rate \<10 breaths/min or SpO₂ \<90% requiring intervention). Secondary outcomes include sedation depth, body movement episodes, recovery time, PONV incidence, and others. Significance: This study aims to provide a sedation and analgesia regimen with lower risk of respiratory depression and faster recovery for elderly patients undergoing ERCP.

Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration

This study is a pragmatic, randomized controlled pilot trial comparing remimazolam with propofol for endoscopic procedures, designed to assess the feasibility and clinical outcomes associated with implementing a pragmatic randomized trial of sedation practices in the endoscopy setting.

Effects of Low-Dose Ketamine Added to Propofol Sedation During Colonoscopy

"This prospective observational study aims to evaluate the effects of adding low-dose ketamine (0.25 mg/kg) to standard propofol sedation on hemodynamic stability, sedation depth, and recovery times in adult patients undergoing elective colonoscopy. Sedation depth will be objectively monitored using the Bispectral Index (BIS) alongside clinical scoring. The study observes and compares two standard sedation regimens routinely used in the clinic: propofol alone versus a combination of propofol and low-dose ketamine. Researchers will record intraoperative hemodynamic parameters (mean arterial pressure, heart rate, oxygen saturation) and BIS values at regular intervals from baseline to the end of the procedure. Furthermore, postoperative recovery quality, cognitive function, and discharge readiness will be comprehensively assessed using the Modified Aldrete Score, Post Anesthetic Discharge Scoring System (PADSS), and a computerized Psychomotor Vigilance Test (PVT-B) at specific time points. The total amount of propofol consumed to maintain adequate sedation will also be compared between the two observational cohorts."

Prospective Multicentre Observational Registry of Peri-procedural Anaesthesia, Sedation and Related Medication Exposure in Patients With Brugada Syndrome

The goal of this observational study is to evaluate the perioperative risk of malignant ventricular arrhythmias in adult patients diagnosed with Brugada Syndrome undergoing anaesthetic procedures. Brugada Syndrome is a rare inherited cardiac condition associated with an increased risk of life-threatening arrhythmias, and perioperative management remains challenging due to limited high-quality evidence. The main questions it aims to answer are: * What is the incidence of malignant ventricular arrhythmias during anaesthesia and up to 30 days after the procedure? * Are anaesthetic drugs traditionally considered "non-recommended" associated with an increased risk of perioperative arrhythmic events? Researchers will also explore the relative contribution of anaesthetic drugs versus perioperative physiological factors (e.g., haemodynamic changes, fever, bradycardia) in triggering arrhythmias. Participants will: * Undergo anaesthetic procedures (general, locoregional, or sedation) as part of routine clinical care * Have clinical data collected prospectively from electronic medical records during the perioperative period * Be followed for 30 days after the procedure to assess outcomes, including arrhythmias, complications, ICU admission, and mortality This is a multicentre, prospective observational registry, and no additional interventions or changes to standard clinical practice will be performed.

The Use of Remimazolam Versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy

This study seeks to compare the clinical efficacy and safety of the novel sedative Remimazolam with Dexmedetomidine in Drug-Induced Sleep Endoscopy (DISE), evaluating their performance in sedation depth stability, incidence of adverse events, and postoperative recovery time, thereby providing evidence-based guidance for sedative selection in OSA patients. Additionally, it aims to develop a model for predicting upper airway obstruction sites by analyzing Polysomnography (PSG) data with artificial intelligence, enhancing diagnostic accuracy and treatment decision-making efficiency for Obstructive Sleep Apnea (OSA) to optimize clinical management.

Effect of Maternal Voice on Pain, Sedation, and Physiological Parameters in Mechanically Ventilated Children

Children in the pediatric intensive care unit often experience pain and stress from medical procedures, even while sedated. This study will test whether playing a recording of the child's mother's voice helps reduce pain and the need for sedation medication in children aged 1 to 3 years who are on a breathing machine (mechanical ventilator). Children will be randomly placed into one of two groups: one group will listen to a 10-minute recording of their mother's voice through headphones, while the other group will receive usual care with no recording. Researchers will measure pain and comfort levels, heart rate, oxygen levels, blood pressure, and breathing rate before, during, and after the session to see if listening to the mother's voice makes a difference.

Sedation Safety Assessment Using IPI Monitoring in Pediatric Hematologic Procedures

Pediatric hematologic procedures such as lumbar puncture and bone marrow aspiration often require deep sedation due to pain and the need for immobility. Sedative and opioid combinations increase the risk of respiratory depression. Integrated Pulmonary Index (IPI) combines SpO₂, EtCO₂, respiratory rate, and heart rate into a single score and may allow earlier detection of respiratory compromise. This study aims to evaluate the safety and effectiveness of IPI monitoring in pediatric patients undergoing hematologic procedures under sedation with BIS monitoring.

Neonatal Neurological Observation With Video AI

NeoNOVA is a multi-site, prospective, single-arm, silent observational study to determine: among (Population) infants admitted to newborn services during their inpatient hospital stay, whether (Intervention) continuous bedside non-contact high definition video running real-time AI analysis of anatomic landmarks and movement, (Comparison) compared against human-labeled video frames and standardized clinical exams, will (Outcome) accurately localize infant anatomic landmarks (primary objective; outcome median position error in pixels) and demonstrate a statistically significant association between a video-derived movement index and clinical measures of patient neurological exams (secondary objective; outcomes N-PASS and modified Sarnat exams).

RemImazolam Besylate for ICU-sedation in Patients With Mechanical Ventilation After Oral and Maxillofacial Surgery

Remimazolam besylate, as a new benzodiazepine drug, showing rapid clearance and moderate distribution of pharmacokinetic changes. The study will further explore the safety and effectiveness of remimazolam besylate n the sedation of mechanically ventilated patients after oral and maxillofacial surgery in the ICU.

Dexmedetomidine Versus Ketamine Loading for Dexmedetomidine Sedation During Elective Cesarean Section Under Spinal Anesthesia

This is a prospective, randomized, double-blind clinical study designed to compare the maternal and early neonatal effects of a loading dose of dexmedetomidine versus low-dose ketamine in parturients undergoing elective cesarean delivery under spinal anesthesia. Participants will be randomly assigned to receive either an intravenous loading dose of dexmedetomidine (1 μg/kg) or intravenous ketamine (0.15 mg/kg) immediately after the establishment of spinal anesthesia. In both groups, sedation will be maintained with a continuous dexmedetomidine infusion at a rate of 0.5 μg/kg/h. The primary and secondary outcomes include maternal hemodynamic parameters, sedation levels, patient and surgeon satisfaction scores, neonatal Apgar scores, and perioperative adverse events.

Sedation in ICU Patients With Mechanical Ventilation

Background: Sedation is a cornerstone of management for mechanically ventilated patients in the intensive care unit (ICU). Achieving early target sedation while maintaining hemodynamic stability remains a major clinical challenge. Ciprofol, a novel intravenous sedative agent structurally derived from propofol, has shown promising efficacy and a potentially improved hemodynamic profile in preclinical and phase II/III studies. However, high-quality evidence from large, multicenter randomized trials in real-world ICU settings is lacking. Objective: To evaluate the efficacy and safety of ciprofol versus propofol for sedation in mechanically ventilated ICU patients, as assessed by the incidence of early successful sedation without hypotension. Methods: This is a multicenter, randomized, double-blind, parallel-group, active-controlled, noninferiority clinical trial conducted across 31 centers in China. A total of 366 patients will be randomized in a 1:1 ratio to receive either ciprofol or propofol. Eligible patients are adults (aged 18-80 years) admitted to the ICU receiving mechanical ventilation, with an expected sedation duration of 6-24 hours and a target Richmond Agitation-Sedation Scale (RASS) of +1 to -2. Key exclusion criteria include known allergy to ciprofol, BMI \<18 or \>30 kg/m², prior sedation for \>3 days, severe cardiovascular, hepatic or renal dysfunction, Glasgow Coma Scale ≤12, expected survival ≤24 hours, pregnancy or lactation, and participation in other drug trials. Patients will receive a loading dose (ciprofol 0.1 mg/kg or propofol 0.5 mg/kg) over 4 minutes, followed by a maintenance infusion titrated to achieve the target RASS. Remifentanil will be used for analgesia throughout. The primary composite outcome is successful sedation without hypotension within 30 minutes of study drug administration, defined as: (1) RASS within the target range of +1 to -2; (2) no use of rescue sedation; and (3) no occurrence of hypotension. Hypotension is defined as systolic blood pressure \<90 mmHg, diastolic blood pressure \<60 mmHg, mean arterial pressure \<70 mmHg, or a \>30% drop from baseline. Secondary outcomes include sedation success without hypotension at 1 hour, sedation without circulatory depression (hypotension or bradycardia) at 1 hour, drug utilization, duration of mechanical ventilation, extubation time, awakening time, delirium incidence (CAM-ICU), ICU length of stay, 28-day mortality, and safety profiles. Based on an assumed 92% incidence in the ciprofol group versus 82% in the propofol group, with a two-sided alpha of 0.05 and 80% power, and allowing for a 5% dropout rate, the required sample size is 183 patients per group, totaling 366 patients. Analysis will be performed on the intention-to-treat population using logistic regression for the primary outcome, with results expressed as risk difference and relative risk with 95% confidence intervals. Ethics and Dissemination: The study protocol has been approved by the ethics committee of the coordinating center and will be submitted to all participating sites. The trial is registered with ClinicalTrials.gov (NCT06538883). Results will be disseminated through peer-reviewed publications and academic presentations. Keywords: Ciprofol, Propofol, Intensive care unit, Mechanical ventilation, Sedation, Hypotension, Randomized controlled trial

Inhaled Sedation in Critically Ill Patients

The proposal of this study is to compare inhaled sedation with isoflurane administered via the Sedaconda ACD-S system with intravenous sedation with propofol. Patients will be randomized 1:1 to receive either inhaled sedation with isoflurane administered via the Sedaconda ACD device (Sedana Medical, Uppsala, Sweden) or intravenous propofol. The primary endpoint is the number of ventilator-free days at 28 days after randomization.

Bispectral Monitoring on Mechanically Ventilated Patients

The purpose of this study is to determine the difference in the duration of mechanical ventilation, to evaluate the difference in ICU length of stay and to determine the difference in the overall dose of sedation medications between the between participants who were monitored using Bispectral index monitoring (BIS) monitors and those who were not.

Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures

This study will compare two different sedation approaches used during gastroscopy, colonoscopy, and endoscopic retrograde cholangiopancreatography (ERCP). One group will receive dexmedetomidine alone (opioid-free sedation), while the other group will receive dexmedetomidine combined with remifentanil (opioid-based sedation). The purpose of the study is to determine whether an opioid-free sedation approach can reduce opioid-related adverse symptoms, such as nausea, vomiting, dizziness, drowsiness, dry mouth, headache, and fatigue. The study will also evaluate quality of recovery, patient and healthcare staff satisfaction, hemodynamic effects, complications, and time to discharge after the procedure.

Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation

A multi-center, prospective, randomized, double-blind, active-controlled, no-inferiority clinical trial conducted across 5 tertiary medical centers in China. The objective of this RCT is to evaluate the sedative efficacy and safety profile of remimazolam besylate compared with dexmedetomidine in patients requiring mechanical ventilation following non-cardiac surgery. The study hypothesized that remimazolam besylate is non-inferior to dexmedetomidine regarding the primary efficacy outcome.

Light and Anesthesia

The objective of this clinical trial is to investigate the effect of light exposure on sedation depth during general anesthesia.The primary research questions this study aims to address include: Does light condition affect the dosage of anesthetic medications during anesthesia? By what mechanism does light exposure exert an influence on anesthesia? Participants will be randomly allocated to either the light-shielded group or the non-light-shielded group.Patients in the light-shielded group will wear an eye shield during anesthesia. The following data will be recorded for all patients: Induction drug dosage Induction time Intraoperative anesthetic dosage Emergence time

Effect of Remimazolam Sedation on Outcomes of Mechanically Ventilated Patients in the ICU

The goal of this clinical trial is to evaluate the effect of remimazolam sedation on outcomes of mechanically ventilated ICU patients through a single-center, prospective, randomized controlled, pilot study.