Anesthesia

20 years ago, for the first time in Spain, a record was made of all the activity carried out by a medical speciality, called ANESCAT 2003. After 20 years, the increase in healthcare activity has exceeded the expectations and predictions that were made at the time. Therefore, it is necessary to make a new assessment of the work situation in which our speciality finds itself in order to be able to evaluate whether the increase in resources allocated has been proportional and therefore to be able to have objective data with a view to making new demands and planning future needs.

The goal of this observational study is to learn about recovery after heart surgery for people with Complex Congenital Heart Disease (CCHD), build a comprehensive data platform for CCHD care across a person's whole life, and create a China-specific quality control system to improve CCHD surgical care. The main questions it aims to answer are: What are the main risk factors that affect how well people with CCHD recover after heart surgery? Can a whole life course, multi-dimensional data platform for CCHD care be built to support better clinical quality control? Can a China-specific system to evaluate and control the quality of CCHD heart surgery be developed to guide national health policies and improve patient outcomes? Participants in this study are people with CCHD who have had or will have heart surgery at participating medical centers. This includes two groups: A retrospective group: People who already had CCHD heart surgery and were included in the existing National Congenital Heart Disease Surgery Database. A prospective group: People who are scheduled to have CCHD heart surgery as part of related sub-studies of this project. People who are lost to follow-up or have more than 30% missing data will not be included. Participants will: For the retrospective group: Have their past medical records (from surgery and follow-up) analyzed by researchers to find risk factors linked to recovery after CCHD heart surgery. For the prospective group: Have their pre-surgery tests, surgery details, care during and after surgery, and follow-up data (including up to 1 year after surgery) collected as part of their regular medical care. Researchers will combine data from both groups into a new registry, work with a third-party committee to check data quality, and use this combined data to build a quality control and evaluation system for CCHD heart surgery. This system will help show the current state of CCHD care in China and guide national health decisions.

This prospective observational study aims to compare the clinical performance of two target-controlled infusion (TCI) models, Eleveld and Schnider, for propofol sedation in mechanically ventilated intensive care unit (ICU) patients. The study evaluates sedation depth, hemodynamic stability, and recovery profiles using the Bispectral Index (BIS) and Riker Sedation-Agitation Scale. Secondary outcomes include awakening time, total propofol dose, and incidence of delirium after sedation withdrawal. The findings may help identify the most reliable pharmacokinetic model for safe and effective ICU sedation.

This study is a prospective, single-center, observational validation study designed to develop and evaluate a reproducible external anatomical landmark for localization of the distal cephalic vein at the forearm in pediatric patients. The study aims to support accurate preprocedural placement of topical local anesthetic (EMLA) and to facilitate subsequent peripheral venous access in children by using ultrasound as the reference standard. Background and Rationale Peripheral venous access in young children is frequently challenging due to limited visibility and palpability of superficial veins. The cephalic vein at the distal forearm is a commonly used site for ultrasound-guided cannulation; however, standardized external anatomical landmarks for preprocedural localization of this vein are lacking, particularly in pediatric patients. As a result, opportunities for timely application of topical anesthetics are often missed, especially in ambulatory and day-surgery settings where parents are required to apply EMLA patches at home prior to hospital admission. Ultrasound provides accurate visualization of superficial venous anatomy and allows objective validation of surface landmark accuracy. This study seeks to define a practical, reproducible landmark for the distal cephalic vein and to assess whether this landmark can be applied reliably by anesthesia professionals as well as by parents or caregivers using a standardized visual instruction guide. Study Design and Setting The study is conducted at a single Swiss university children's hospital and consists of two sequential, non-interventional study parts. All ultrasound examinations are performed intraoperatively after induction of general anesthesia for clinically indicated elective surgery. No venipuncture or deviation from standard clinical care is performed as part of the study. Each participant contributes data at a single time point only. No follow-up visits or longitudinal assessments are planned. Study Procedures Study Part 1 - Pilot Phase (Landmark Development): In an initial pilot phase, ultrasound examinations of the distal cephalic vein are performed in a cohort of pediatric patients under general anesthesia. The vein's course, depth, and diameter are assessed, and the vein's trajectory is marked on the skin with a washable marker. Photographic documentation of the forearm is obtained. Based on these sonographic measurements and images, a reproducible external anatomical landmark is developed for use in the validation phase. Study Part 2 - Validation Phase: The predefined anatomical landmark is evaluated in two independent validation steps: Step 1 (Anesthesia Staff Application): Anesthesia professionals apply the landmark by marking the presumed vein location on the forearm using a washable marker, guided by a standardized visual instruction. After induction of anesthesia, ultrasound is used to determine whether the cephalic vein is located beneath the marked area and to document anatomical parameters. Step 2 (Parent/Caregiver Application): Parents or caregivers apply an EMLA patch to the forearm using the same visual instruction guide prior to surgery. After induction of anesthesia, the patch is removed and ultrasound examination is performed to assess whether the cephalic vein is located beneath the area covered by the patch. In both validation steps, ultrasound measurements are performed by anesthesia personnel not involved in the initial marking to reduce observer bias. Ultrasound Assessment Ultrasound examinations are performed using high-frequency linear probes suitable for pediatric vascular imaging. The following parameters are documented at the marked site: * Presence of the cephalic vein within the marked or EMLA-covered area * Distance between the center of the vein and the center of the marked area * Vein depth from the skin surface * Vein diameter * Proximal course of the vein over a distance of up to 3 cm All measurements are obtained with the patient under general anesthesia to avoid movement-related variability. Data Collection and Management Study data are recorded using standardized paper Case Report Forms (CRFs) and subsequently transferred to a secured electronic database. Data are pseudonymized at the time of collection. Ultrasound images and photographic documentation are stored digitally to allow verification if required. Source data include CRFs, ultrasound images, and relevant routine clinical data (e.g., age, weight). No biological samples are collected, and no questionnaires or laboratory tests are performed. Quality Assurance and Monitoring Several measures are implemented to ensure data quality and consistency: * Standardized ultrasound procedures and documentation checklists * Training and briefing of all participating sonographers * Use of standardized visual instruction guides for landmark application * Partial double data entry and random data checks * Internal monitoring by the principal investigator * Secure storage and version control of all study documents * The study may be subject to audits or inspections by the responsible ethics committee, with direct access to source data if required. Sample Size Considerations This is an exploratory, non-confirmatory study. A formal power calculation was not performed. The planned sample size for the validation phase is based on achieving sufficient precision in estimating the proportion of correctly localized veins. Inclusion of approximately 30 participants per validation subgroup allows estimation of the primary accuracy measure with acceptable confidence interval width for an exploratory anatomical validation study. Statistical Analysis Principles Data analysis is primarily descriptive. Continuous variables are summarized using measures of central tendency and dispersion, while categorical variables are summarized using proportions and confidence intervals. Exploratory analyses assess relationships between anatomical parameters and demographic variables such as age, body weight, and body mass index. No interim analyses are planned. Handling of Missing Data Missing data may occur due to technical limitations or incomplete documentation. Analyses are performed using available data only, without imputation. If the number of evaluable cases falls below predefined targets, recruitment may be extended to ensure adequate data completeness. Ethical and Safety Considerations The study involves minimal risk. All procedures are non-invasive and performed under general anesthesia as part of routine clinical care. No additional pain, radiation exposure, or biological sampling is involved. Data protection measures include pseudonymization during data collection and anonymization after completion of the analysis. The study is conducted in accordance with applicable ethical and regulatory requirements.

The study rationale is that prior to conducting a multisite randomized trial, it is necessary to identify relevant outcomes, understand barriers to greater use of local anesthesia, test study procedures, and confirm our ability to adequately recruit and randomly assign participants. Additionally, the proposed study will provide the applicant with critical training in the design, conduct, and analysis of clinical trials. This will uniquely position the applicant to change surgical care for older adults. More specifically, the investigators plan to demonstrate the ability to successfully randomize Veterans aged 60 years and older to local versus general anesthesia for inguinal hernia surgery, and to validate processes and instruments to measure relevant outcomes. Although the original NIA-approved proposal involved only two arms, open hernia repair using local anesthesia and open repair using local anesthesia, the study team subsequently published a paper that showed using local anesthesia for open hernia repair may also be superior to laparoscopic or robotic hernia repair. Consequently, a third arm is added to our pilot study: laparoscopic or robotic hernia repair with general anesthesia (these surgical approaches cannot be done using local anesthesia). The rationale is that use of laparoscopic or robotic inguinal hernia surgery, while still less common than open repair, is becoming more common and no prior randomized trials have compared laparoscopic/robotic surgery versus open repair using local anesthesia. Local or general anesthesia are the primary methods of anesthesia for inguinal hernia surgery for most surgeons (though some perform the operation under spinal or regional anesthesia, this is rare). Both approaches are used in clinical practice with acceptable known risks and complications. General anesthesia is associated with risks of hypotension, venous thromboembolism, heart attack, stroke, pulmonary dysfunction, cognitive dysfunction, allergic reaction, urinary retention, and malignant hyperthermia. The main risks of local anesthesia include allergic reaction and hypotension (when the anesthetic is improperly injected into a blood vessel). The primary objective is to: 1. demonstrate ability to successfully recruit, randomize, and retain patients aged 60 years and older for a randomized trial of local versus general anesthesia for inguinal hernia surgery, and 2. establish the ability to measure relevant outcomes and test protocols and study instruments for measuring key outcomes. The secondary objective is to generate preliminary comparisons between the study arms, to inform effect size estimates for a larger multisite trial.

With the approval of Ethics Committee of the McGill University Health Centre, a total of 69 patients undergoing upper extremity surgery (elbow and below) will be recruited. Recruitment will be carried out by an investigator not involved in patient care one day before surgery All ICBs will be supervised by the coauthors and conducted preoperatively in an induction room. After skin disinfection and draping, the ICB will be performed with a previously described technique. In each group, a proven 90% effective volume of 35 mL of local anesthetic solution will be injected. As LA solution, it will be used a mixture of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL plus PN 2 mg dexamethasone. The injectate will be slowly injected through the block needle. Patients will be randomized to receive the study drug, PN dexmedetomidine 0.67 mcg/kg or PN dexmedetomidine 1 mcg/kg, or PN dexmedetomidine 1.33 mcg/kg mixed with the above-mentioned LA solution. A research assistant (licensed anesthesiologist) will prepare the local anesthetic solutions and will add the study drug following the randomization order. The operator, patient, and investigator assessing the block will be blinded to group allocation. The primary outcome will be the duration of the motor block (defined as the temporal interval between the end of LA injection through the block needle and the return of movement to the hand and fingers) for patients with successful ICBs. Patients will be provided with a data sheet and asked to record the time at which motor function returns. An investigator blinded to group allocation will collect this data sheet in person (inpatients) or by phone (outpatients) on postoperative day 1.

INTRODUCTION Many newborn infants have difficulty breathing after birth. Some of these babies have a tube inserted into their "windpipe" (trachea) - an endotracheal tube (ETT) - through which they are given breathing support (ventilation). When clinicians attempt to intubate (insert an ETT), they use an instrument called a laryngoscope to view the airway in order to identify the entrance to the trachea (larynx). Standard laryngoscopes have a "blade" (which, despite its name, is not sharp) with a light at the tip. Doctors insert the blade into the baby's mouth to view the larynx. Traditionally, clinicians used a standard laryngoscope to look directly into the baby's mouth to view the larynx (direct laryngoscopy, DL). When clinicians attempt to intubate newborns with DL, less than half of first attempts are successful. Also adverse effects - such as falls in the blood oxygen levels (fall in oxygen saturation (SpO2), or "desaturation"), slowing down of the heart rate (bradycardia), oral trauma - are relatively common. In recent years, video laryngoscopes (VL) have been developed. In addition to a light, VL have a video camera at the tip of the blade. This camera acquires a view of the larynx and displays it on a screen that the clinician views when attempting intubation (indirect laryngoscopy). In a randomised study performed at the National Maternity Hospital, Dublin, Ireland, more infants were successfully intubated at the first attempt when clinicians used VL compared to DL \[79/107 (74%) versus 48/107 (45%), P\<0.001\]. While this study was large enough to show that VL resulted infants being successfully intubated at the first attempt in one hospital, it couldn't give information about how it might work in a range of hospitals, and it wasn't large enough to see what effect VL had on adverse events. There is a large difference in cost between a standard laryngoscope (approx. €300) and a video laryngoscope (approx. €21,000). This is a matter of concern for all hospitals, particularly in settings where resources are more limited. The investigators aim to assess whether VL compared to DL results in more infants being intubated at the first attempt without physiological instability. STUDY DESIGN A recent single centre study reported that that more newborn infants were successfully intubated at the first attempt when VL was used to indirectly view the airway compared to DL. This study was not large enough to determine the effect of VL on adverse effects that are seen commonly (e.g. desaturation) or more rarely (e.g. bradycardia, receipt of chest compressions or adrenaline, oral trauma) during intubation attempts. For the current study, the investigators chose a stepped-wedge cluster randomised controlled design, where the participating centre, rather than the individual infant, will be the unit of randomisation. This design has been found appropriate to test the effects of an intervention that encompasses a behavioural aspect and to implement interventions while studying them at the same time. In this study, all centres will begin in the "control group"; where clinicians will routinely attempt intubation with DL, as is their usual practice. At specified intervals, centres will be randomly assigned to cross over to the "intervention group", where clinicians will routinely attempt intubation with VL. All participating centers will have included patients in both arms by the end of the study. SAMPLE SIZE ESTIMATION To determine the intra-cluster correlation (that means the correlation between two observations from the same centre), the investigators used the dataset of the MONITOR trial that included infants from 7 delivery rooms worldwide. In this trial, the intra-cluster correlation for intubation in the delivery room was reported as 0.1. This complete stepped-wedge cluster-randomized design includes 21 time periods (including the baseline) and 20 centres that will be including patients, with each randomised to a unique sequence. Each time period lasts a fortnight. Each time period, 1 centre will switch their treatment from DL to VL. With all centres including 2 patients each time period, 42 patients will be included per centre which will provide a total sample size of 840 patients. Assuming a control proportion of 0.4, this sample will achieve 90% power (0.9091) to detect a treatment proportion of 0.55, assuming a conservative ICC of 0.05. The power is not very sensitive to ICC values up to 0.1 (power of \>90% to detect difference 40% versus 56%). The test statistic used is the two-sided Wald Z-Test. TREATMENT OF SUBJECTS DIRECT LARYNGOSCOPY (DL, control period) At the start of the study, clinicians at participating centres will attempt intubation using a standard laryngoscope to perform DL as is their normal practice. VIDEO LARYNGOSCOPY (VL, intervention period) For each centre, a lot will be drawn which indicates the month in which endotracheal intubation will be routinely attempted with VL rather than DL. In the month before the switch, centres will be provided with a C-MAC VL by the manufacturers, Karl Storz-Endoskop (Tuttlingen, Germany). The system will be provided on loan for the duration of the study and will consist of an 8" high-definition monitor with connecting cable and reusable straight Miller type blades size 0 and size 1. The equipment will be demonstrated by representatives from Karl Storz, and clinicians who intubate babies at participating hospitals will be encouraged to practice with the equipment on mannequins. We will have an virtual meeting with each centre in the week before they are due to switch to review the protocol, data collection and to answer any queries that they may have. All other procedures in the delivery room and NICU will be performed according to international and local guidelines. All other aspects of the approach to intubation at the participating centre are at the discretion of the local clinicians and should remain the same for the duration of the study; e.g.: * The drugs used before intubation attempts (e.g. opiate, atropine, curare-like drug) * The route by which intubation is usually attempted (i.e. oral or nasal) * Whether they use a stylet is routinely used * Whether supplemental oxygen is given during attempts

The study is being conducted to evaluate the safety and efficacy of bupivacaine liposome injection for local infiltration analgesia in pediatric orthopedic surgery in the real world.

The purpose of this study is to understand changes in heart function (how the heart pumps blood) and blood flow in people who receive general anesthesia during surgery. The researchers are particularly interested in the heart function and blood flow changes in people who experience low blood pressure (hypotension) after receiving anesthesia.

To observe and study the clinical effect of Huperzine A Injection on reducing postoperative delirium in elderly patients undergoing non-cardiac surgery