Incidence of Postoperative Residual Curarization

NCT06193213 | Completed

• 1 other identifier: 5991
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Neuromuscular Blockade, Residual

Outcome Measures

Primary Outcomes (1)

• postoperative residual neuromuscular block

  evaluation of the incidence of postoperative residual neuromuscular block upon arrival in the post-anesthesia care unit (PACU), defined as a TOFR≤0.9, by acceleromyographic method in interventions in which non-depolarizing neuromuscular blockers with intermediate duration of action were administered at the time of tracheal intubation and/or for maintaining a condition of myoresolution during surgery.

  within 5 minutes from admission in the postoperative care unit

Secondary Outcomes (2)

• number of respiratory adverse events

  within 7 days

• evaluation of possible risk factors for residual curarization

  4 months

Interventions

measurement of train of four ratio (TOFR) to assess residual neuromuscolar block PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients undergoing surgery under general anesthesia with the use of non-depolarizing neuromuscular blocking agents at intermediate duration of action, to facilitate tracheal intubation and/or for maintaining a condition of myoresolution during surgery

You may qualify if:

• Adult patients aged ≥ 18 years, American Society of Anesthesiologists (ASA) physical status I-III, who have expressed written consent to participate in the study and who will undergo surgery under general anesthesia with the use of non-depolarizing neuromuscular blocking agents at intermediate duration of action, to facilitate tracheal intubation and/or for maintaining a condition of myoresolution during surgery.

You may not qualify if:

• Patients undergoing emergency surgery, who do not require the administration of non-depolarizing neuromuscular blockers, patients with neuromuscular pathologies, or who require postoperative monitoring in the Intensive Care Unit.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00100, Italy

Location

Related Publications (1)

• Piersanti A, Garra R, Sbaraglia F, Del Vicario M, Lamacchia R, Rossi M. Neuromuscular monitoring and incidence of postoperative residual neuromuscular blockade: a prospective observational study. J Anesth Analg Crit Care. 2025 Jan 28;5(1):5. doi: 10.1186/s44158-025-00226-1.

  PMID: 39875976 DERIVED

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alessandra Piersanti, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 5, 2024
• Study Start: February 1, 2024
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: February 26, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)