Incidence of Postoperative Residual Curarization (PORC)

Incidence of Postoperative Residual Curarization, a Prospective Observational Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Neuromuscular Blockade, Residual
• Intervention / Treatment: Procedure: measurement of train of four ratio (TOFR) to assess residual neuromuscolar block

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.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Alessandra Piersanti, MD; Phone Number: +393398443082; Email: alessandra.piersanti@policlinicogemelli.it

Study Locations

• Italy
  • Rome, Italy, 00100
    • Fondazione Policlinico Universitario Agostino Gemelli Irccs
    • Contact: Alessandra Piersanti, MD; Phone Number: +393398443082; Email: alessandra.piersanti@policlinicogemelli.it
    • Contact: Fabio Sbaraglia, PhD; Phone Number: +393497730144; Email: fabio.sbaraglia@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of respiratory adverse events	Number of any adverse respiratory events that occurred during the stay in the PACU and during the hospital stay. Respiratory adverse events will be defines as episodes of desaturation (SpO2<92%) requiring oxygen supplementation or the finding of atelectasis, pneumonia or pleural effusion of non-cardiac origin found on thoracic imaging tests possibly performed during the hospital stay;	within 7 days
evaluation of possible risk factors for residual curarization	Estimation of a logistic regression model to define risk factors for residual curarization Will be considered as possible risk factors those reported in the literature : the patient's age, the duration of anesthesia, the type of anesthesia administered (inhalation or totally intravenous), the number of administrations and the total dose of neuromuscular blocker, reversal or not of the neuromuscular blockade, the antagonist drug and the type of neuromuscular blocker used during surgery [7].	4 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Alessandra Piersanti, MD, Fondazione Policlinico Universitario Agostino Gemelli Irccs

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia
• Other Study ID Numbers: 5991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No