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TOFNCT07758868

Residual Neuromuscular Blockade and PACU Admission

An observational study of TOF, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
TOF
How many people
179 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Aug 2026to 28 Sep 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients aged 18-90 years, classified as American Society of Anesthesiologists (ASA) physical status I-IV, who underwent elective surgery under general anesthesia and received a neuromuscular blocking agent were eligible for inclusion in the study.

Patients aged 18-90 years, classified as American Society of Anesthesiologists (ASA) physical status I-IV, who underwent elective surgery under general anesthesia and received a neuromuscular blocking agent were eligible for inclusion in the study.

Patients younger than 18 years or older than 90 years, those requiring postoperative invasive mechanical ventilation and transfer to the intensive care unit while intubated, patients undergoing emergency surgery, and those with a pre-existing neuromuscular disorder were excluded.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gizem Avcı

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Incidence and Clinical Implications of Residual Neuromuscular Blockade in Patients Planned for Post-Anesthesia Care Unit Admission: A Prospective Observational Study

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-IV 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.

Read the detailed description

Residual neuromuscular blockade (RNMB) remains an important patient safety concern throughout the postoperative period and continues to be underrecognized by healthcare professionals. Current evidence suggests that RNMB is associated with an increased risk of postoperative pulmonary complications, prolonged length of stay in the post-anesthesia care unit (PACU), and reduced patient satisfaction.

Clinical assessment methods may include, but are not limited to, a 5-second head lift, sustained hand grip, eye opening, tongue protrusion, and the presence of spontaneous ventilation. Although these tests are commonly used by anesthesiologists, they lack sufficient sensitivity and specificity for the detection of RNMB.

The 2023 American Society of Anesthesiologists Practice Guidelines for Monitoring and Antagonism of Neuromuscular Blockade provide recommendations regarding the use of quantitative neuromuscular monitoring in conjunction with pharmacological reversal to improve the recognition of RNMB and reduce its incidence. These guidelines recommend quantitative monitoring because it enables more reliable confirmation of a train-of-four ratio (TOFR) of ≥0.9 compared with qualitative assessment methods.

The use of quantitative neuromuscular monitoring to assess the depth of neuromuscular blockade may substantially reduce the risk of RNMB in patients undergoing general anesthesia. Several studies have also investigated whether combining pharmacological reversal of neuromuscular blockade with quantitative monitoring may further improve postoperative patient safety.

Patients scheduled for postoperative admission to the PACU commonly have significant comorbidities and higher American Society of Anesthesiologists physical status classifications. Therefore, postoperative RNMB may be particularly critical in this high-risk patient population. The present study was designed to evaluate postoperative neuromuscular recovery in accordance with current evidence-based guidelines.

Patients aged 18-90 years, classified as American Society of Anesthesiologists (ASA) physical status I-IV, who underwent elective surgery under general anesthesia and received a neuromuscular blocking agent were eligible for inclusion in the study.

Patients younger than 18 years or older than 90 years, those requiring postoperative invasive mechanical ventilation and transfer to the intensive care unit while intubated, patients undergoing emergency surgery, and those with a pre-existing neuromuscular disorder were excluded.

Preoperative demographic and clinical data, including age, sex, body weight, height, body mass index, comorbidities, smoking status, and preoperative serum creatinine levels, were recorded using the patients' study identification numbers. The type and duration of surgery were also documented for each patient.

The type and dose of the neuromuscular blocking agent administered during general anesthesia were recorded. At the end of surgery, whether pharmacological reversal of neuromuscular blockade was performed was documented, together with the type and dose of the reversal agent used. The interval between the last dose of the neuromuscular blocking agent and administration of the reversal agent, as well as the time from reversal to recovery, was recorded.

Once the patients fulfilled the Aldrete recovery criteria, they were transferred to the postoperative recovery unit. Routinely monitored physiological parameters, including blood pressure, peripheral oxygen saturation, heart rate, and body temperature, were recorded.

In accordance with the recommendations of the 2023 American Society of Anesthesiologists Practice Guidelines for Monitoring and Antagonism of Neuromuscular Blockade, postoperative residual neuromuscular blockade was assessed at the adductor pollicis muscle using TOFscan® acceleromyography (Dräger® Technologies, Mississauga, ON, Canada). TOFscan® is a quantitative neuromuscular monitor that uses three-dimensional acceleromyography. The stimulating electrodes were placed on the skin over the ulnar nerve at the wrist, 3 cm apart, and the electrical stimulus intensity was set at 30 mA to provide an appropriate balance between adequate monitoring and patient comfort.

Neuromuscular function was assessed at the 10th postoperative minute in both the recovery unit and the post-anesthesia care unit. The decision regarding postoperative follow-up in the PACU or the surgical ward was made by the attending physicians according to the patients' clinical condition.

Postoperative adverse events, including nausea and vomiting, dyspnea, and deterioration in vital signs, were recorded throughout the perioperative and postoperative periods.

Conditions
TOF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07758868
Study groupRoleWhat they receive
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 admissionPatients for whom postoperative admission to the post-anesthesia care unit (PACU) was not planned during the preoperative assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative residual neuromuscular blockade incidance (RNMB)

    Quantitative train-of-four (TOF) monitoring was performed perioperatively, and RNMB was defined as a TOF ratio <0.90 during postoperative assessment.

    Measured: Perioperative period, including intubation, extubation and until the 30th postoperative minute.

Secondary outcomes (3)
  1. Association between reversal agent type and RNMB

    association between reversal agent type and RNMB.

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

  2. postoperative respiratory complications

    postoperative respiratory complications

    Measured: postoperative follow-up period for 24 hours

  3. RNMB incidence between patients planned for PACU admission and those planned for ward follow-up

    comparison of RNMB incidence between patients planned for PACU admission and those planned for ward follow-up

    Measured: perioperative period, including intubation, extubation and until the 30th postoperative minute.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2026
  2. Study start10 Aug 2026
  3. Primary completion15 Sep 2026
  4. Study completion28 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07758868
Sponsor's protocol ID
AEŞH-EK-2025-159
Status last verified
Sep 2026
First submitted
6 Aug 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40247184
  • 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.

    PubMed 31926308
  • 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.

    PubMed 40119713

Questions about this trial

What is this clinical trial studying?

An observational study of TOF, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative residual neuromuscular blockade incidance (RNMB) (time frame: Perioperative period, including intubation, extubation and until the 30th postoperative minute.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07758868, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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