Residual Neuromuscular Blockade and PACU Admission

NCT07758868 | Not Yet Recruiting

• 1 other identifier: AEŞH-EK-2025-159
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Residual neuromuscular blockade (RNMB) remains an underrecognized postoperative safety concern associated with pulmonary complications, prolonged post-anesthesia care unit stay, and reduced patient satisfaction. Because conventional clinical tests are insufficiently sensitive and specific, current guidelines recommend quantitative neuromuscular monitoring to confirm adequate recovery, defined as a train-of-four ratio of ≥0.9. This prospective observational study included adult patients aged 18-90 years with ASA physical status I-III who underwent elective surgery under general anesthesia with neuromuscular blocking agents. Demographic, clinical, anesthetic, surgical, and reversal-related variables were recorded. Postoperative neuromuscular recovery was quantitatively assessed at the adductor pollicis muscle using TOFscan® acceleromyography at the 10th postoperative minute. Patients were subsequently followed in either the PACU or surgical ward according to clinical indications, and postoperative adverse events were documented. The study aimed to evaluate the incidence and potential determinants of RNMB in accordance with contemporary neuromuscular monitoring guidelines.

Conditions

TOF

Outcome Measures

Primary Outcomes (1)

• The primary outcome of this study was to investigate the incidence of postoperative residual neuromuscular blockade in patients identified as high risk during the preoperative assessment and to evaluate the associated clinical differences.

  Patients scheduled for postoperative admission to the post-anesthesia care unit generally represent a population with a greater burden of comorbidities and higher American Society of Anesthesiologists physical status classifications. Therefore, postoperative residual neuromuscular blockade may be of greater clinical significance in this patient population. This study was designed to evaluate postoperative neuromuscular recovery in accordance with current guideline recommendations.

  Perioperative period, including follow-up until the 30th postoperative minute.

Secondary Outcomes (1)

• seconder outcome

  From the preoperative assessment through the intraoperative period and during the postoperative follow-up period for 24 hours.

Study Arms (2)

Patients scheduled for postoperative admission to the post-anesthesia care unit (PACU)

No study-specific intervention was planned for either group. Patients whose postoperative admission to the post-anesthesia care unit (PACU) had been planned on the basis of the preoperative assessment and the decision of the attending physician constituted the PACU group.

Patients scheduled for ward admission

Patients for whom postoperative admission to the post-anesthesia care unit (PACU) was not planned during the preoperative assessment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 18-90 years with American Society of Anesthesiologists (ASA) physical status I-III who underwent elective surgery under general anesthesia and received a neuromuscular blocking agent.

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Gizem Avcı

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• Vishneski SR, Saha AK, Tran LC, Fernando RJ, Acharya SK, Lee LK, Templeton LB, Brooks AK, Smith LD, Templeton TW. Risk factors for administration of additional neuromuscular block reversal in adults undergoing general anaesthesia: a single centre retrospective case-control study. BMC Anesthesiol. 2025 Apr 17;25(1):189. doi: 10.1186/s12871-025-03009-x.

  PMID: 40247184 RESULT

• Plaud B, Baillard C, Bourgain JL, Bouroche G, Desplanque L, Devys JM, Fletcher D, Fuchs-Buder T, Lebuffe G, Meistelman C, Motamed C, Raft J, Servin F, Sirieix D, Slim K, Velly L, Verdonk F, Debaene B. Guidelines on muscle relaxants and reversal in anaesthesia. Anaesth Crit Care Pain Med. 2020 Feb;39(1):125-142. doi: 10.1016/j.accpm.2020.01.005. Epub 2020 Jan 8.

  PMID: 31926308 RESULT

• Linn DD, Rech MA, Faine BA. Strategies to prevent awareness with paralysis following administration of neuromuscular blocking agents. Am J Health Syst Pharm. 2025 Aug 19;82(17):e736-e742. doi: 10.1093/ajhp/zxaf072.

  PMID: 40119713 RESULT

Study Officials

• gizem avcı

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

gizem avcı, MD, Anesthesiologist

CONTACT

+905327144658; drgizemavci@gmail.com

gizem avcı

CONTACT

drgizemavci@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following publication of the study results.
• Access Criteria: Data will be shared after approval of the request and, where required, completion of a data-use agreement. No directly identifiable participant information will be provided.

Locations

TU (1)