An observational study in Residual Paralysis, Post Anesthesia, Postoperative Complications and Neuromuscular Blockade, sponsored by University Hospital Ulm. Active, not recruiting at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by University Hospital Ulm · Observational
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.
The objective of the PINES project is to identify a model that can accurately predict 1) time to complete neuromuscular recovery, 2) optimal timing and dose of neuromuscular blocking agents at each time point during surgery, and 3) TOF ratio at the estimated end of surgery to assess residual paralysis. Furthermore, a prospective clinical pilot study will be conducted to compare anesthesiologist-predicted neuromuscular recovery with that of the algorithm.
The project consists of two main objectives:
I. Big data analysis
II. Prospective comparison of the prediction: machine-learning model vs. anesthesiologist
Using the validated final prediction model with the best accuracy, the investigators will perform a prospective clinical pilot study. The cohort will include prospectively enrolled adult surgical patients undergoing general anesthesia with a single dose of rocuronium for neuromuscular blockade. For each enrolled case, both the PINES algorithm and an experienced anesthesiologist will estimate the time to neuromuscular recovery, defined as a train-of-four (TOF) ratio > 0.9.
At anesthesia induction, following administration of the neuromuscular blocking agent, participating specialist-level anesthesiologists will prospectively estimate the time in minutes until recovery of neuromuscular transmission. The PINES machine-learning model will generate its prediction. The actual recovery time will be determined from the continuously recorded intraoperative TOF measurements.
The agreement between the predicted and observed recovery times will be assessed by calculating the difference between predicted and actual values, as well as by determining inter-rater correlation coefficients comparing anesthesiologist predictions, algorithm predictions, and the measured recovery times.
In a secondary analysis, there will be evaluated whether the choice of neuromuscular blocking agent influences postoperative pulmonary complication risk in adult patients. Confounding will be addressed using statistical methods based on a causal inference framework.
98 studies on the registry are indexed under Delayed Emergence from Anesthesia; 17 are open to participants now.
This study's planned enrollment of 240,000 is above the median of 100 across 39 observational studies indexed under Delayed Emergence from Anesthesia.
Browse Delayed Emergence from Anesthesia studies →University Hospital Ulm is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients (≥18 years) receiving non-cardiac surgery receiving neuromuscular blocking agents and with available TOF data.
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Exclusion Criteria:
Patients receiving a single dose of neuromuscular blocking agent
Patients receiving repetitive doses of neuromuscular blocking agents
Patients receiving pharmacological reversal of neuromuscular block
complete neuromuscular recovery
predicting the time to complete neuromuscular recovery (defined as TOF ratio \>0.9) from any time point of surgery
Time frame: intraoperative
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Delayed Emergence from Anesthesia →
University Hospital Ulm