NCT06193213

Incidence of Postoperative Residual Curarization

Incidence of Postoperative Residual Curarization, a Prospective Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 90 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

An incomplete postoperative recovery of neuromuscular function (postoperative residual curarization - PORC) represents a common problem in post-anesthesia care units (PACU), potentially exposing the patient to adverse respiratory events. Quantitative and objective evaluation of neuromuscular function using the train acceleromyographic method -of-four ratio (TOFR) at the level of the adductor muscle of the thumb represents the best way to minimize this risk after administration of non-depolarizing neuromuscular agents. Study endpoints Primary endpoint * incidence of postoperative residual curarization Secondary endopoints * number of possible respiratory adverse events during the stay in the PACU and during the hospital stay * estimation of a logistic regression model to define the risk factors associated with residual curarization

Detailed description

Neuromuscular blocking agents are commonly used in clinical anesthetic practice to facilitate tracheal intubation and allow muscle relaxation during surgical interventions. Anesthesiologist's subjective qualitative assessment of the patient's recovery of muscle strength before extubation is not predictive of adequate neuromuscular recovery even if many surveys conducted at an international level \[1,2,3\] demonstrate how this modality of evaluation is often used above all due to the not always widespread availability of tools for quantitative monitoring of neuromuscular blockade3. An incomplete recovery of neuromuscular function at the end of surgery (Postoperative residual curarization - PORC) exposes the patient to potential adverse respiratory events and a Consensus Statement \[4\] of experts in 2018 suggested a quantitative and objective evaluation of neuromuscular function using the train acceleromyographic method -of-four ratio (TOFR) at the level of the adductor muscle of the thumb represents the best way to minimize this risk after administration of non-depolarizing neuromuscular agents. In case of TOFR ≤ 0.9, reversal of the neuromuscular block is normally performed with drugs belonging to the class of acetylcholinesterase inhibitors (e.g. neostigmine 0.03-0.05 mg/kg, associated with an antimuscarinic agent such as atropine to counteract the cholinergic effects) or by sugammadex (2 or 4 mg/Kg), a selective antagonist of rocuronium and vecuronium which acts by encapsulating the neuromuscular blocking molecule making it ineffective. Recurrence of neuromuscular blockade may, however, occur primarily due to mechanisms of redistribution of the muscle relaxant or if insufficient doses of the reversal drug are administered.

Conditions

• Neuromuscular Blockade, Residual

Interventions

Type	Name	Description
PROCEDURE	measurement of train of four ratio (TOFR) to assess residual neuromuscolar block	Upon arrival of the spontaneously breathing patient in the Post-Anesthesia Care Unit, a researcher will evaluate the TOFR to detect any residual neuromuscular block using the acceleromyographic method at the level of thumb adductor.2 TOFR measurements will be performed 30 seconds apart. If the difference between the two measurements will be ≤ 0.1, the average value will be considered for the purposes of the analysis. In case of a difference \> 0.1, a third measurement will be taken and the average of the two closest results will be considered. If a residual block is detected sugammadex will be administered (2 mg/kg in the case of at least 2 contraction responses to TOF stimulation or 4 mg/kg in the case of no contraction response) to restore normal neuromuscular function , assessed by subsequent TOFR measurement.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2024-01-05
• Last updated: 2025-02-26

Locations

1 site across 1 country: Italy