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Active, not recruitingNCT05471882PINESUpdated May 7, 2026

Predicting Neuromuscular Recovery in Surgical Patients Using Machine Learning

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

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
240,000
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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

  • Establishing a data warehouse: Electronic registry data will be used.
  • Generation of prediction models: Classification models will first be used to identify and weight the relevant parameters collected during premedication and intraoperatively. These will form the basis for the training cohort, which can then be used to carry out a simulated real-time analysis of the data. To compare the models, the loss functions mean squared error, mean absolute error and Huber Loss will be calculated.

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.

02

Conditions studied

  • Residual Paralysis, Post Anesthesia
  • Postoperative Complications
  • Neuromuscular Blockade
  • Quantitative Neuromuscular Monitoring

Keywords

  • Neural Networks, Computer
  • Monitoring, Intraoperative
  • Artificial Intelligence
  • Time Factors
03

In context

Delayed Emergence from Anesthesia

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients (≥18 years) receiving non-cardiac surgery receiving neuromuscular blocking agents and with available TOF data.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients (≥18 years) undergoing non-cardiac surgery receiving general anesthesia with intraoperative neuromuscular blocking agent administration and available TOF data.

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
240,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Single neuromuscular blocking agent dose

    Patients receiving a single dose of neuromuscular blocking agent

  • Incremental doses of neuromuscular blocking agents

    Patients receiving repetitive doses of neuromuscular blocking agents

  • Pharmacological reversal

    Patients receiving pharmacological reversal of neuromuscular block

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

2 sites
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05471882
Lead sponsor
University Hospital Ulm
Responsible party
Flora Scheffenbichler (Clinician Scientist, University Hospital Ulm) — Principal investigator
First posted
Jul 25, 2022
Start date
Mar 1, 2024
Primary completion
Sep 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
May 7, 2026

Study contacts

Manfred Blobner, MD PhD
principal investigator · Department of Anesthesiology and Intensive Care Medicine, University of Ulm,Ulm, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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