Clinical Research Directory

Comparison of an Acceleromyography- and Electromyography-based Neuromuscular Monitor With TOF-Watch ® Monitor

A quantitative neuromuscular monitoring device is desirable to titrate the depth of neuromuscular block (NMB) during a procedure, and to prevent residual effects after removal of the endotracheal tube. Unfortunately, the most widely used monitoring technique acceleromyography (AMG) typically implies a series of cumbersome installation and calibration procedures that frequently precludes correct use of these devices in clinical practice. Electromyography (EMG) has recently attracted a lot of attention as an alternative strategy to compensate for the deficiency of AMG-based neuromuscular monitors. Nowadays, a new technology that allows for the simultaneous acquisition of EMG and AMG signals is commercially available. Although its reliability has been rapidly accepted in Physical Medicine and Rehabilitation, the use of the technique in neuromuscular monitoring has never been reported. The aim of the present study is to assess the validity of the new device for estimating the neuromuscular block by comparing with TOF Watch®-SX, which is the most widely accepted AMG-based neuromuscular monitor that has been practiced in the clinical arena for decades.

Safety and Efficacy of HRS-9190 Compared to Rocuronium for Bolus Maintenance in Adults

The study will enroll adult patients scheduled for elective surgery requiring general anesthesia. Participants will be randomly assigned to receive either HRS-9190 for Injection or Rocuronium. The primary objective is to measure the duration from the last dose of the study drug until the recovery of neuromuscular function to a specific level (TOFr ≥ 90%). Secondary objectives include evaluating the onset time and duration of action following each dose, the total time adequate muscle relaxation is maintained during surgery, and the detailed pattern of neuromuscular recovery. Safety assessments will include monitoring of adverse events, vital signs, laboratory parameters, and other safety indicators throughout the study period. The hypothesis of this study is that HRS-9190 for Injection could provide effective neuromuscular relaxation, with a satisfied safety profile in the target patient population.

Safety and Efficacy of HRS-9190 Compared to Cisatracurium for Continuous Intravenous Infusion in Adults

The study will enroll adult patients scheduled for elective surgery requiring general anesthesia. Participants will be randomly assigned to receive either HRS-9190 for Injection or Cisatracurium. The primary objective is to measure the duration from cessation of the study drug infusion until the recovery of neuromuscular function to a specific level (TOFr ≥ 90%). Secondary objectives include onset time, duration of action, total time of adequate muscle relaxation during surgery, and neuromuscular recovery pattern.. Safety assessments will include monitoring of adverse events, vital signs, laboratory parameters, and other safety indicators throughout the study period. The hypothesis of this study is that HRS-9190 for Injection could provide effective neuromuscular relaxation, with a satisfied safety profile in the target patient population.

Sarcopenia and Neuromuscular Block in Gastrointestinal Cancer Surgery

This prospective observational study aims to evaluate the effects of sarcopenia on intraoperative neuromuscular block (NMB) in patients undergoing gastrointestinal cancer surgery. Adult patients scheduled for elective gastrointestinal cancer surgery will be grouped as sarcopenic or non-sarcopenic based on preoperative abdominal CT scans. Neuromuscular block parameters, including onset time, depth, duration, and recovery, will be objectively measured using TOF (Train-of-Four) monitoring. The study seeks to determine whether sarcopenia influences sensitivity to muscle relaxants and to contribute to individualized anesthesia management and patient safety.

TetraGraph to Evaluate Onset and Recovery Times of Rocuronium

In most clinical instances, direct laryngoscopy and endotracheal intubation is performed after a set time (generally 60 seconds) following the administration of a neuromuscular (NM) blocking agent, rocuronium. Although the average onset time is 60 seconds, clinical studies show a standard deviation around the mean onset time of 10-20 seconds, meaning that a significant number of patients do not achieve complete NM blockade by 60 seconds. Given the above noted variability, complete NM blockade may not be achieved in 60 seconds in a significant percentage of patients, resulting in more problematic direct laryngoscopy and endotracheal intubation. Various studies have shown a higher incidence of perioperative respiratory events and postoperative concerns (sore throat, vocal cord injury) when NM blockade is not complete prior to endotracheal intubation. This study aims to use the TetraGraph monitor to clearly identify onset times of rocuronium. Additionally, whenever feasible based on the clinical needs of the case, recovery times after the single dose of rocuronium will be recorded.

Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease

The purpose of the study is to determine which combination of neuromuscular blocking agent and reversal agent is safer to use during anesthesia for patients with chronic kidney disease. The main question it aims to answer is "The use of Cisatracurium with neostigmine leads to less post-operative pulmonary complications than Rocuronium with sugammadex."

Comparison of the Performances of the cTOFR and the mTOFR During Reversal of Deep Neuromuscular Blockade With Sugammadex

It is known that deep neuromuscular block improves surgical conditions, especially during laparoscopic abdominal surgery. Based on this, in the Perioperative Neuromuscular Blockade Management guide published by the ESAIC association in 2022, it is recommended to deepen the level of neuromuscular blockade in cases where surgical conditions need to be improved. Sugammadex should be used to quickly and reliably reverse deep neuromuscular blockade. TOFScan, a 3-dimensional acceleromyograph for neuromuscular monitoring, has become widely used in recent years. With this monitor, it has been shown that in addition to the classical train-of-four ratio (cTOFR), the modified train-of-four ratio (mTOFR) can be used during the spontaneous recovery of nondepolarizing neuromuscular blockade. In a study conducted by Schmartz et al. in 2021, it was shown that mTOFR, which is the ratio of T4 to the reference stimulus, was compiled later than cTOFR. Therefore, it is suggested that the mTOFR value is a better determinant for safe extubation.

Median Versus Ulnar Nerve Quantitative Electromyography Neuromuscular Blockade Monitoring Comparison

Medications used to relax the muscles are used during surgery. The amount of muscle relaxation can monitored with devices that stimulate a specific nerve and evaluate the muscle response. The response to, and recovery from, medications that relax the muscles are best described for a nerve in the arm called the ulnar nerve. The investigators believe that other nerves in the arm, such as the median nerve, could be used to monitor the amount of muscle relaxation. The purpose of this study is to compare the muscle response at two different nerve sites after giving medications to relax the muscles. This study is going to measure the depth of muscle relaxation during surgery at two different sites. The muscle response to stimulation of the ulnar nerve (located in the arm) will be compared to the muscle response to stimulation of the median nerve (also located in the arm).

NMBA Reversal and Postoperative Urinary Retention

In this single-center retrospective cohort study of adult patients who underwent surgery under general anesthesia at Beth Israel Deaconess Medical Center between September 2016 and January 2024, the association between the choice of neuromuscular blocking agent (NMBA) reversal strategy, comparing sugammadex with neostigmine (combined with a muscarinic antagonist), and postoperative urinary retention (POUR) will be evaluated. In secondary analyses, the effects of NMBA reversal strategy and POUR on costs of care and unplanned hospital visits will be analyzed.

Partial Neuromuscular Blockade in Acute Hypoxemic Respiratory Failure

PNEUMA is a preliminary safety and feasibility trial of a novel approach to the titration of neuromuscular blockade (NMB) to safe spontaneous breathing in patients with moderate to severe acute hypoxemic respiratory failure (AHRF) supported with invasive mechanical ventilation.

Predicting Neuromuscular Recovery in Surgical Patients Using Machine Learning

Despite emerging efforts to decrease residual paralysis and postoperative complications with the use of quantitative neuromuscular monitoring and reversal agents their incidences remain high. In an optimal setting, neuromuscular blocking agents are dosed in a way that there is no residual block at the end of surgery. The effect of neuromuscular blocking agents, however, is highly variable and is not only influenced by their dose, but also by several patient-related factors such as muscle status, metabolic activity, and anesthesia management. Accordingly, the duration of action is difficult to predict. The PINES project will use artificial intelligence methods to develop a model that can accurately predict the course of action of neuromuscular blocking agents. It will be used to predict time to complete neuromuscular recovery (train-of-four \[TOF\] ratio \>0.9) and may provide as a decision support in the individual management of timing and dosing of neuromuscular blocking drugs and their reversal agents. In a secondary analysis, the association between the choice of neuromuscular blocking agent and postoperative pulmonary complications will be evaluated.

Reversal of Neuromuscular Blockade During the General Anaesthesia

There are individual reports indicating that after the reversal of nondepolarizing neuromuscular blockade with neostigmine, some patients starts to relax spontaneously again after the tof ratio has already recovered to the safe level (\>90%). The mechanism behind this in not well understood, and the incidence of the phenomenon is unclear. In this study the investigators try to determine the incidence of the aforementioned postrecovery relaxation.

Neuromuscular Monitoring in Children (6 Months - 2 Years) With Electromyography and Acceleromyography

The aim of this study is to compare AMG and EMG (Philips IntelliVue NMT module and Senzime TetraGraph) in the objective monitoring of neuromuscular blocking in children between the age of 6 months and 2 years.The monitoring will be done bilaterally either on n.ulnaris or n. tibialis. The hypothesis of the study is that AMG will indicate faster recovery time (time to return to TOF 90%) from neuromuscular block than EMG.

Erector Spinae Block vs. Placebo Block Study

Regional anaesthesia combined with general anaesthesia has become common in the perioperative management of breast cancer surgery patients. Regional techniques have been recognised to provide excellent post-operative analgesia. It enhances multi-modal analgesia regimes while being opioid sparing, reducing incidence of post-operative nausea and vomiting and allowing earlier mobilisation/discharge and improving treatment success. Therefore identifying the correct regional anaesthetic technique for this group of patients is important in providing optimum peri-operative care.

LIA vs. LIA + ACB-iPACK Block for Total Knee Arthroplasty

LIA is the mainstay of postoperative analgesia in patients having knee arthroplasty. The combination of ACB-iPACK blocks has also been proposed as an effective analgesic modality for total knee arthroplasty. However, whether combining these two modalities yields any important incremental analgesic benefit remains unclear. The investigators hypothesized that the addition of ACB and iPACK blocks to LIA will yield clinically important analgesic benefits compared to LIA alone in patients having total knee arthroplasty.

Deep Neuromuscular Blockade on Postoperative Pain

This study aims to investigate the impact of varying degrees of neuromuscular blockade on postoperative pain in pediatric patients aged over 2 months to under 7 years undergoing laparoscopic surgery under general anesthesia.

Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery

Frailty among patients undergoing surgery is strongly associated with an elevated risk of adverse perioperative outcomes, heightened incidence of postoperative complications, increased mortality rates, and prolonged hospital length of stay. Our focus centers on investigating the frailty index in the context of complications experienced by patients undergoing oncologic gynecology surgery. The principal objective of this research is to elucidate the extent to which residual neuromuscular blocking agents are linked to frailty.

International Focus Group Discussion on Neuromuscular Monitoring.

Focus-Group based discussion designed to gain more in-depth information on factors that could lead to an increase in the adoption of neuromuscular monitoring taking into account different country-specific contexts.

Evaluation of Neuromuscular Blockade Responses in Statin-Using and Non-Using Patients

This study aims to compare the neuromuscular blockade responses in patients undergoing elective surgery under general anesthesia, with a focus on the use of statins. The study will assess the depth of neuromuscular blockade, recovery time, and postoperative residual curarization using Train-of-Four (TOF) monitoring, with the primary goal of determining whether statin use alters the neuromuscular blockade management.

The Clinical Effect of Sugammadex Sodium (Domestic) for Antagonizing Neuromuscular Blockade After Thoracic Surgery

This study aims to compare the use of sugammadex (domestic) and neostigmine for antagonism after thoracic surgery, and observe the effect of sugammadex (domestic) on neuromuscular blockade antagonism after thoracic surgery, in order to provide a basis for optimizing the use of muscle relaxants and their antagonists during anesthesia.

Ephedrine for Reducing Onset Time of Rocurinium in Elderly Patients

The aim of this study is to determine the onset time of rocuronium after administration of ephedrine 0.15 mg/kg in patients with age ≥ 80 years. The hypothesis of this study is that ephedrine 0.15 mg/kg provides a shorter onset time compared to placebo (saline).

Abdominal Muscle Volume and a Neuromuscular Blocking Agent

With the recent development of image analysis and artificial intelligence, it has become possible to measure the muscle volume from preoperative computed tomography (CT) images. Therefore, in this study, the investigators quantify the muscle volume from preoperative CT images and analyze the correlation with the dose of neuromuscular blocking agent, rocuronium, required for maintaining deep neuromuscular blockade.

Skeletal Muscle Index and a Neuromuscular Blocking Agent

With the recent development of image analysis, it has become possible to measure the skeletal muscle index representing the subject's muscle mass from preoperative computed tomography (CT) images. Therefore, in this study, the investigators quantify the skeletal muscle index from preoperative CT images and analyze the correlation with the dose of neuromuscular blocking agent, rocuronium, required for maintaining deep neuromuscular blockade.

High Dimensional Analysis of Immune Cells in Pediatric Patients

The purpose of this study is to characterize immune cells using single-cell transcriptomic analysis in pediatric patients aged 2 to 18 years undergoing general anesthesia who are expected to receive Rocuronium, a non-depolarizing neuromuscular blocking agent, in the event of an allergic reaction.