Clinical Research Directory

Oral Dexmedetomidine in Pediatric MRI

The objective of this preliminary study is to assess the utility of oral dexmedetomidine as the sole sedative agent in pediatric population undergoing MRI.

The Million Anesthesia Cases Study (MACS) - a Cohort Study of Preoperative Fasting and Perioperative Outcomes

Perioperative fasting has historically been viewed as a low-risk intervention. However, preliminary data indicate that perioperative loss of nutrition and fluids is likely harmful. This study intends to characterize perioperative fasting practices and their potential effects on clinical outcomes through possible effects on patient well-being (anxiety, hunger, thirst), physiology (hypovolemia, hypotension), perioperative aspiration, etc. The research team hypothesized that in addition to known adverse effects on patients' well-being, prolonged preoperative fasting adversely affects circulating blood volume-related (hypotension, decreased urine output etc.) and glucose metabolism-related (e.g., hypo/hyperglycemia) perioperative physiology. The investigators will also test for an association between the duration of preoperative fasting and the risk of perioperative pulmonary aspiration. Additional knowledge on the potential adverse effects of preoperative fasting will inform preoperative fasting policies and research interventions that are relevant to hundreds of millions of patients subjected to preoperative/preprocedural fasting worldwide each year.

Cognitive Assessment And Post-Operative Complications After Surgery: Linking Anaesthesia And Risk

Many older people can experience confusion, memory problems, or a decline in their thinking after major surgery. These problems are sometimes called 'postoperative neurocognitive disorders' or PND and can affect recovery and a person's ability to live independently. The investigators want to find out the best way to study these problems in older patients undergoing surgery. This is a 'feasibility study', which means we are testing the research methods. The investigators want to see if it is possible to ask participants to do memory tests and give blood samples before and after their operation. The investigators are hoping to include around 40 patients over 2 years in this study. The investigators will compare performance in memory (cognitive assessment) findings before and after surgery and link this to data taken from the anaesthetic, including the types of drugs used, duration, brain features from processed electroencephalogram monitoring and standard recommended monitoring. In addition the investigators will link this to blood sample markers of brain health and function (biomarkers). The results of this study will help the investigators plan a much larger study in the future, with the ultimate goal of making surgery safer for the brain.

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

Artificial Intelligence vs. Automated Messaging for Continuous Regional Analgesia Follow-up

Effective postoperative analgesia is critical for patient recovery, satisfaction, and the reduction of hospital stay duration. Continuous peripheral nerve blocks (CPNB) via catheter placement represent a cornerstone in achieving these objectives. Traditionally, follow-up for these patients has relied on standardized telephone protocols conducted by trained personnel. Original previous research in 2024 demonstrated that an automated text-messaging platform was feasible and maintained high patient satisfaction, it resulted in a significantly higher rate of unscheduled patient-initiated inquiries (28.3% vs. 6.4%) compared to traditional phone calls, likely due to a lack of adaptive response capabilities. Objective: This study aims to evaluate an enhanced technological iteration of our follow-up platform. By integrating an Artificial Intelligence (AI) interface trained on specialized clinical protocols, the new system is designed to provide automated, personalized and adaptive recommendations to patients. Methods and Intervention: The study will compare the effectiveness of this AI-driven platform against the previous version of the non-adaptive automated messaging system. The primary outcome is to compare the number of patient-initiated inquiries (re-consultations). Secondary outcomes include patient satisfaction, adherence to the follow-up protocol, and response rates from postoperative days one through three. Impact: The investigators hypothesize that the integration of AI will optimize human resources and improve patient autonomy without compromising safety or satisfaction, ultimately providing a scalable model for postoperative regional analgesia monitoring.

Remimazolam NeuroImaging

This is a single-arm functional MRI study that will determine the effects of remimazolam on cognition and brain activity and connectivity at rest, during noxious stimulation, and during a memory encoding task

Ketamine and Propofol NeuroImaging

This is a multi-visit which will collect MRI (pictures of the brain) and EEG (brain waves) data to determine changes in brain connectivity and brain activity for memory formation and pain perception while receiving the commonly-used anesthetic agents ketamine and propofol, both alone and in combination.

Impact of Combined Intravenous-Inhalational vs Inhalational Anesthesia on QoR-15 Recovery Scores in Gynecologic Surgery

This study aims to compare the effects of combined intravenous-inhalational anesthesia versus inhalational anesthesia alone on postoperative recovery in patients undergoing elective gynecologic surgery. A total of 100 patients, aged 18-65 years and classified as ASA I-III, scheduled for elective gynecologic procedures at Sakarya University Faculty of Medicine Training and Research Hospital, will be included. The sample size was calculated based on the primary outcome, the Quality of Recovery-15 (QoR-15) score. Patients will complete the QoR-15 questionnaire preoperatively, before knowing which anesthesia method will be applied. Postoperative QoR-15 scores will be collected on postoperative days 1 and 2, and intraoperative data will be obtained from anesthesia records. The study evaluates postoperative recovery using QoR-15 scores, covering physical comfort, emotional state, psychological support, pain, and ability to perform daily activities. Higher scores indicate better recovery, whereas lower scores indicate impaired postoperative recovery.

Sustainable Anesthesia in Myocardial Revascularization Surgery.

* Introduction: Greenhouse gases threaten the health and safety of humanity. The Declaration of Helsinki seeks to protect human health and emphasizes the urgency of implementing sustainable strategies. Sustainability is defined by three pillars: economic (costs), social (clinical effectiveness), and environmental (environmental impact). Clinical effectiveness in cardiac surgery has a new paradigm: "optimized recovery," which translates into fewer complications, earlier extubation, shorter ICU stays, and potential cost reductions. The objective of this study is to compare the sustainability of the optimized recovery anesthetic technique with standard anesthetic practice in coronary artery bypass graft surgery, using a non-randomized interventional study design. * Methods: Patients aged 18 years or older with coronary artery disease scheduled for elective coronary artery bypass graft surgery will be recruited. Combined procedures and reinterventions will be excluded. Sample size: The optimized recovery group is expected to reduce postoperative mechanical ventilation by two hours. With a 95% confidence interval, 80% power, and a 1:3 ratio between the groups, a sample size of 29 and 87 patients was estimated for the optimized recovery and standard anesthesia groups, respectively. * The optimized recovery technique includes, preoperatively, oral pregabalin 75 mg, fasting, no benzodiazepines, total intravenous anesthesia, low-dose intravenous fentanyl, methadone 0.1-0.2 mg/kg IV, erector spinae plane block with 0.25% bupivacaine (20 mL per side), and postoperative nausea and vomiting prophylaxis with dexamethasone. Postoperatively, administer paracetamol 1 g IV every 6 hours, NSAIDs, and methadone 1 mg IV as needed. The standard anesthetic technique involves the anesthesiologist administering anesthesia as they have routinely done prior to the study, without changes. * Four anesthesiologists will participate in the study. Only one anesthesiologist will perform the OR technique, and their results will be compared with those of the other three, who will use their standard anesthetic technique. Patient assignment is independent, based on the hospital's schedule. * Analysis: The clinical effectiveness of each technique will be evaluated based on ICU extubation time. An economic analysis will be conducted based on average costs, and critical environmental impacts will be estimated through a life-cycle assessment. * Outcome: The performance of the indicator "Costs in Euros/CO2e/Extubation Time" will be studied. These will contribute to the estimation of an anesthetic strategy that addresses the challenges of sustainable medicine, reduces emissions, and enables the rational use of resources and their associated costs, offering environmentally friendly and clinically effective health solutions.

PrediSuisse: Automatized Assessment of Difficult Airway

In the "PrediSuisse" research project, the investigators aim to create a reliable, reproducible, ultra-portable and radiation-free automatized software, able to identify automatically collected features, facial characteristics, and range of movements, to predict intubation difficulty. The software will generate a difficulty intubation score tailored to three commercially available videolaryngoscopes with different type of blades, corresponding to the predicted endotracheal intubation difficulty while providing the anaesthesiologist a reliable and non-subjective tool to assess individual patient's risks with regards to airway management.

Effect of Glycemic Control on Intraoperative NIRS and Postoperative Recovery in Diabetic Patients

This prospective observational study aims to evaluate the effect of glycemic control level on intraoperative cerebral oxygenation measured by near-infrared spectroscopy (NIRS) and postoperative recovery in patients with diabetes mellitus undergoing elective urologic surgery under general anesthesia. Patients will be grouped according to HbA1c levels to assess the relationship between long-term glycemic control and intraoperative regional cerebral oxygen saturation, hemodynamic parameters, and postoperative recovery scores.

The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ankle Blocks

Peripheral nerve blocks are essential in ensuring effective regional anesthesia and postoperative analgesia in forefoot surgery for hallux valgus repair, with or without minor concomitant toe procedures. Many factors influence the onset and duration of peripheral nerve blocks. In the advent of ultrasound-guided nerve blocks, the accuracy in administering LA has significantly improved, potentially reducing the required dosage, which is also associated with less risk for toxicity. However, the effect of the concentration of LA on the onset time and duration of ultrasound-guided ankle blocks for forefoot surgery has not yet been studied. This poses a clinically relevant dilemma regarding the necessity of administering lower or higher concentrations of ropivacaine to achieve a clinically relevant faster onset time and longer duration of an ankle block.

Evaluation of SaCoVLM™ Video Laryngeal Mask for Airway Management in Military Medics

A prospective, two-phase interventional study evaluating the performance, safety, and usability of the SaCoVLM™ video laryngeal mask airway for airway management by military medics with limited intubation experience. The study includes simulation-based training and clinical application in sedated patients undergoing elective surgery.

Effect of Visual Aids Added to Informed Consent on Patient Understanding and Anesthesia Awareness

This prospective cluster-randomized controlled study aims to evaluate whether visual support material provided in addition to the standard written informed consent form improves patients' comprehension of informed consent and their level of anesthesia awareness in an anesthesia outpatient clinic setting. Patients presenting to the anesthesia outpatient clinic will be allocated in clusters to receive either standard written informed consent alone or standard consent supplemented with structured visual support material. All patients will receive standardized verbal information delivered by the same anesthesiologist. Thirty minutes after the information session, comprehension of informed consent and anesthesia awareness levels will be assessed using a structured questionnaire administered in a standardized manner by a blinded anesthesiologist. The primary objective is to determine whether visual support enhances patient understanding of informed consent. Secondary objectives include evaluating its effect on anesthesia-related risk awareness and overall anesthesia knowledge.

pEEG-Guided Anesthesia and Behavioral Outcomes in Children

Post-hospitalization behavioral changes are common in children after surgery and general anesthesia and may persist for varying durations depending on individual and perioperative factors. The Post-Hospitalization Behavior Questionnaire (PHBQ) is a well-validated instrument widely used to evaluate negative postoperative behavioral changes in pediatric patients following hospitalization or surgical procedures. Although early postoperative behavioral disturbances have been extensively studied, most research has focused on short-term outcomes within the first weeks after surgery, while long-term behavioral outcomes remain insufficiently investigated. Processed electroencephalography (pEEG) monitoring provides an objective method for assessing anesthetic depth during surgery. Parameters such as the Patient State Index (PSI) and Spectral Edge Frequency 95 (SEF95) allow dynamic evaluation of cortical activity and may help optimize anesthetic administration by preventing excessively deep or inadequate anesthesia. Improved anesthetic depth management may theoretically influence postoperative recovery and behavioral outcomes. In the initial randomized study, early postoperative behavioral assessments were obtained within the first postoperative month using the Post-Hospitalization Behavior Questionnaire (PHBQ). In the present follow-up study, children will be contacted again 12-24 months after surgery to evaluate long-term behavioral outcomes. PHBQ scores at long-term follow-up will be compared between children who previously received EEG-guided anesthesia and those managed with standard anesthesia without processed EEG monitoring. By examining both early and long-term behavioral outcomes, this study aims to determine whether intraoperative EEG-guided anesthesia management influences postoperative behavioral changes in the pediatric population.

Low-flow Versus Minimal-flow Sevoflurane Anesthesia During Robot-assisted Laparoscopic Radical Prostatectomy

Study Synopsis This protocol is formatted for ClinicalTrials.gov-style registration and manuscript-facing documentation. It is based on the uploaded Turkish ethics protocol and keeps the original core design: comparison of low-flow and minimal-flow sevoflurane anesthesia in robot-assisted laparoscopic radical prostatectomy. Background and Rationale Robot-assisted laparoscopic radical prostatectomy (RALRP) is increasingly preferred for localized prostate cancer because of lower blood loss, reduced transfusion requirements, shorter hospitalization, and lower complication rates compared with open surgery. However, RALRP requires carbon dioxide pneumoperitoneum and steep Trendelenburg positioning, both of which may adversely affect respiratory mechanics, gas exchange, and hemodynamic stability. Low-flow and minimal-flow anesthesia may improve humidification and warming of inspired gases, reduce inhalational agent consumption, decrease environmental waste, and potentially lower overall cost. Despite these theoretical and practical advantages, evidence remains limited regarding the physiologic safety and performance of minimal-flow sevoflurane anesthesia during long robotic pelvic surgery performed under pneumoperitoneum and steep Trendelenburg positioning. Accordingly, this randomized prospective trial will compare low-flow (1 L/min) and minimal-flow (0.5 L/min) sevoflurane anesthesia during RALRP with respect to respiratory parameters, arterial blood gas values, intraoperative oxygenation variables, anesthetic consumption, and selected postoperative biochemical markers.

The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Surgery

Low blood pressure, also known as hypotension, is very common during major surgery under general anesthesia. Prolonged or severe hypotension can lead to complications such as kidney injury after surgery that slow down patient recovery. Anesthesiologists commonly administer medications called vasopressors to treat low blood pressure during surgery. These medications help raise the blood pressure back up to a safe range. Two vasopressor medications are commonly used for this purpose: norepinephrine and phenylephrine. Each of these medications has slightly different effects on the heart and blood vessels (cardiovascular system). It remains unknown which of these standard medications is better for treating low blood pressure during surgery. The goal of this clinical trial is to determine which of these two medications is better at preventing injury to the kidneys after major noncardiac surgery as well as other complications such as heart problems. Major surgeries are defined as those lasting at least two hours under general anesthesia. This trial will randomize about ten centers in North America to use either norepinephrine or phenylephrine as the primary medication to treat low blood pressure in adults undergoing major noncardiac surgery. Each hospital will prioritize one of the drugs each month, and the assigned drug will rotate each month at each hospital. No further participant involvement will be required as de-identified data are collected as part of standard medical care.

Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery

Cesarean section (CS) is one of the most frequently performed surgical procedures globally, with an increasing demand for safe and effective anesthesia techniques. Regional anesthesia, particularly intrathecal anesthesia, has become the method of choice for elective cesarean deliveries.The most commonly used local anesthetic for intrathecal anesthesia is bupivacaine.Recent studies have focused on adjunctive agents to enhance the efficacy of local anesthetics.

EEG Signal Correlates During Anesthesia and Sedation in Adults and Children

This prospective, multicenter, non-interventional observational study investigates the correlates between electroencephalographic (EEG) signals and pharmacological/clinical parameters during general anesthesia and procedural sedation. The study will enroll 330 participants across three distinct populations at two AP-HP sites (Bichat-Claude Bernard Hospital and Louis Mourier Hospital): 1. Pediatric cohort (n=110): Children aged 1-17 years undergoing general anesthesia, including 55 with autism spectrum disorder (ASD) and 55 without ASD. 2. Elderly adult cohort (n=110): Patients over 70 years undergoing scheduled surgery under general anesthesia. 3. Procedural sedation cohort (n=110): Adults ≥18 years undergoing procedural sedation for digestive endoscopy. EEG data will be collected using BIS and SedLine monitors during routine anesthetic care with no modifications to standard practice. The primary objective is to identify EEG signal features correlating with clinical and pharmacological parameters during induction, maintenance, and emergence phases. Secondary objectives include developing predictive models for anesthetic depth, analyzing age-related differences, comparing effects of different anesthetic agents, and investigating specific EEG patterns in children with ASD. This study will enhance understanding of brain responses to anesthesia across different age groups and clinical contexts, potentially improving anesthetic monitoring algorithms and management strategies.

Prospective IR-led Sedation Feasibility

This study wants to see if some interventional radiology (IR) procedures can be done without using general anesthesia. General anesthesia needs a lot of staff and equipment. It can also cause side effects. There are not enough anesthesia providers, which makes it harder to use for every procedure. The researchers will test deep sedation with ketamine instead. They will start with 20 patients. If it works well and is safe, they may include up to 40 patients. Patients will be asked to join the study before their procedure. The anesthesia team will be told ahead of time and will be ready to help if needed. The IR team will give the deep sedation and follow all safety rules. The main goal is to finish the procedure without stopping early or switching to general anesthesia. The study will call this successful if fewer than 10% of cases fail. The researchers will also look at patient pain, patient satisfaction, any side effects, and how long recovery takes.

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.

Drawing Therapy for pReoperative Anxiety in Waiting (DRAW)

This study will use a factorial design to compare the effects of different colors and shapes on patients' preoperative anxiety.

Optimized Strict Fluid Management Helps Improve Endpoints After Liver Dissection

During hepatectomy, surgeons often prefer to restrict fluid intake, believing that this can lower central venous pressure (CVP) and reduce intraoperative blood loss. However, fluid restriction may lead to inadequate perfusion of vital organs and even contribute to postoperative organ dysfunction, such as acute kidney injury (AKI). Therefore, this study aims to compare the effects of restrictive versus liberal fluid therapy on major complications following hepatectomy.

Frequency of Electrical Acupoint Stimulation on Hypotension During Induction

Within 30 minutes before anesthesia, acupoint electrical stimulation at different frequencies were applied at Neiguan and Jian Shi. The changes in blood pressure during the anesthesia induction period were compared between the high-frequency group and the low-frequency group.