Predicting Neuromuscular Recovery in Surgical Patients Using Machine Learning

NCT05471882 | Active Not Recruiting

• 1 other identifier: TOF-R Prediction
• Study Type: observational
• Target: 240,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

Neural Networks, Computer; Monitoring, Intraoperative; Artificial Intelligence; Time Factors

Outcome Measures

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

  intraoperative

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital Ulm: lead
• Technical University of Munich: collaborator

Study Sites (2)

University Hospital Ulm

Ulm, Baden-Wurttemberg, 89073, Germany

Location

Technical University Munich

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manfred Blobner, MD PhD

  Department of Anesthesiology and Intensive Care Medicine, University of Ulm,Ulm, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 25, 2022
• Study Start: March 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2025-12

Locations

DE (2)