TOFNCT07758868
Residual Neuromuscular Blockade and PACU Admission
An observational study of TOF, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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.
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 group | Role | What 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 admission | Patients 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.
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)
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.
postoperative respiratory complications
postoperative respiratory complications
Measured: postoperative follow-up period for 24 hours
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.
- First posted11 Aug 2026
- Study start10 Aug 2026
- Primary completion15 Sep 2026
- Study completion28 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TOFStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gizem Avci, Ankara Etlik City Hospital
- Investigators
- gizem avcı, Principal investigator, Ankara Etlik City Hospital
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 40247184Plaud 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 31926308Linn 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Clinical Implications of Residual Neuromuscular Blockade in Patients Planned for Post-Anesthesia Care Unit Admission: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07758868
- Acronym / sponsor ID
- AEŞH-EK-2025-159
- Conditions
- TOF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 28 Sep 2026 (actual)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative residual neuromuscular blockade incidance (RNMB)
Time frame: Perioperative period, including intubation, extubation and until the 30th postoperative minute.
Quantitative train-of-four (TOF) monitoring was performed perioperatively, and RNMB was defined as a TOF ratio <0.90 during postoperative assessment.
3 secondary outcomes
Association between reversal agent type and RNMB
Time frame: From the preoperative assessment through the intraoperative period and during the postoperative follow-up period for 24 hours.
postoperative respiratory complications
Time frame: postoperative follow-up period for 24 hours
RNMB incidence between patients planned for PACU admission and those planned for ward follow-up
Time frame: perioperative period, including intubation, extubation and until the 30th postoperative minute.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Results publication: PubMed 40247184Vishneski 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.
- Results publication: PubMed 31926308Plaud 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.
- Results publication: PubMed 40119713Linn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
gizem avcı principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
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.