An observational study in Gynecologic Cancer, Neuromuscular Blockade and Residual Neuromuscular Block, sponsored by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital · Observational
The use of neuromuscular blocking (NMB) agents in modern anesthesia is essential for optimizing surgical exposure and ensuring patient safety. Inadequate neuromuscular recovery at the end of surgery, known as residual curarization, poses significant risks for critical postoperative respiratory complications, aspiration pneumonia, and prolonged recovery times. Therefore, objective neuromuscular monitoring is strongly recommended by international guidelines, including the American Society of Anesthesiologists (ASA) and the European Society of Anaesthesiology and Intensive Care (ESAIC).
In gynecologic oncology surgery, laparoscopic and robotic approaches often require deep neuromuscular blockade (Post-Tetany Count 1-2) to improve abdominal exposure and allow surgeons to work at lower intraperitoneal pressures. However, the extreme Trendelenburg position and the "tucked-in" positioning of the arms under surgical drapes limit the feasibility of traditional acceleromyography (AMG) monitoring methods. Since AMG devices require free movement of the thumb (m. adductor pollicis), they can yield false-positive or unreliable results when the arms are inaccessible, forcing clinicians to rely on subjective monitoring.
The NMTCuff technology, used by the Vision Duo monitor, measures the neuromuscular response via the contraction pressure of the upper arm muscles (m. triceps/biceps brachii) rather than the wrist. Literature indicates that the response of upper arm muscles correlates better with the diaphragm and laryngeal muscles regarding NMB sensitivity compared to the wrist. This feature suggests that the Vision Duo might detect the recovery of respiratory functions earlier and more reliably.
This study aims to evaluate the correlation and time differences in Train-of-Four (TOF) ratios between the NMTCuff and standard AMG methods during gynecologic oncology surgery. Additionally, it will assess the ease of setup and signal continuity of both devices when the patient's arms remain covered under surgical drapes.
This study is purely prospective and observational in terms of clinical management. The neuromuscular monitoring methods used will not interfere with routine anesthesia care, drug dosing, muscle relaxant reversal strategies, or extubation decisions. The clinician performing the anesthesia management will follow the institutional routine protocol, and data from both devices will only be recorded simultaneously and matched for statistical comparison.
Following approval from the institutional non-interventional clinical research ethics committee and obtaining written and verbal informed consent from all participating patients, this prospective study will be conducted on patients scheduled for elective laparoscopic gynecologic oncology surgery. Patients aged 18-75 years with an American Society of Anesthesiologists (ASA) physical status of I-III will be included. Exclusion criteria consist of a known history of neuromuscular disease, severe hepatic or renal insufficiency, a Body Mass Index (BMI) greater than 35 kg/m2, and patient refusal to participate.
Upon arrival in the operating room, standard monitoring will be applied to all patients, including electrocardiography (ECG), peripheral oxygen saturation (SpO2), and non-invasive blood pressure (NIBP). Anesthesia induction will follow a standardized routine institutional protocol: propofol 2-3 mg/kg, remifentanil 0.5-1 mcg/kg, and rocuronium 0.6 mg/kg to facilitate endotracheal intubation and induce neuromuscular blockade.
Simultaneously, two different neuromuscular monitoring methods will be applied to each patient as follows:
Group 1 - NMTCuff (Vision Duo): Measurements will be performed using a specialized NMT cuff belonging to the Vision Duo monitor. This cuff is placed around the patient's non-dominant upper arm, and neuromuscular transmission is assessed via pressure-sensitive sensors during muscle contraction.
Group 2 - AMG (Standard TOF): Measurements will be performed using a standard acceleromyography (AMG) Train-of-Four (TOF) sensor attached to the contralateral wrist along the ulnar nerve pathway.
At the end of the surgical procedure, routine reversal of the neuromuscular blockade will be performed using Sugammadex at a dose of 2 mg/kg. The recovery times-specifically the duration from the exact moment of Sugammadex administration until the TOF ratio reaches 90% and 100% (matching the Vision Duo Auto-Pilot specification)-will be recorded separately for both devices using a digital stopwatch. Clinical assessment parameters at the time of extubation, including tidal volume and the 5-second head lift test, will also be documented.
This study is purely prospective and observational regarding clinical anesthesia management. The alternative monitoring methods will not intervene in or alter the routine anesthesia care, muscle relaxant dosages, reversal strategies, or extubation decisions. The attending clinician will manage the patient according to the standard operating room practices, and data from both devices will only be recorded simultaneously and matched for subsequent statistical analysis.
98 studies on the registry are indexed under Delayed Emergence from Anesthesia; 17 are open to participants now.
This study's planned enrollment of 45 is below the median of 100 across 39 observational studies indexed under Delayed Emergence from Anesthesia.
Browse Delayed Emergence from Anesthesia studies →Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital is the lead sponsor of 75 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 10, 2026. See what changed
Female patients aged 18-75 years with an ASA status of I-III who are scheduled to undergo elective laparoscopic gynecologic oncology surgery at Dr. Abdurrahman Yurtarslan Oncology Training and Research Hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single cohort of patients where each patient receives two different neuromuscular transmission (NMT) monitoring methods simultaneously on opposite arms during elective laparoscopic gynecologic oncology surgery.
Other: Dual Neuromuscular Transmission Monitoring
Simultaneous recording and matching of data from two different neuromuscular monitoring devices: NMTCuff (Vision Duo) utilizing pressure-sensitive sensors on the non-dominant upper arm, and standard Acceleromyography (AMG) on the contralateral wrist. This monitoring is part of the standard routine anesthesia care and does not interfere with clinical decisions.
Time to Neuromuscular Recovery (TOF Ratio >= 0.90)
The time interval (measured in minutes) from the exact moment of the neuromuscular blockade reversal agent (Sugammadex 2 mg/kg) administration until the Train-of-Four (TOF) ratio reaches 90%. This recovery time will be tracked and recorded simultaneously for both the NMTCuff (Vision Duo) and the standard acceleromyography (AMG) devices using a digital stopwatch to evaluate the limits and correlation between the two monitoring methods.
Time frame: From the exact moment of Sugammadex administration up to endotracheal extubation (approximately 10 to 20 minutes).
Technical Feasibility and Signal Continuity Under Surgical Drapes
Evaluation of device installation ease, maintenance of stable sensor connections, and the frequency/duration of any signal loss during the operation. This measure assesses the clinical utility of both devices specifically when the patient's arms are tucked-in along their sides and completely covered under surgical drapes in the extreme Trendelenburg position.
Time frame: From the initiation of anesthesia monitoring in the operating room until the end of the surgical procedure (up to 4 hours).
Plan to share: No
Ran from Sep 2026 to primary completion in Nov 2026, 2 months.
Of 21 observational studies under Delayed Emergence from Anesthesia, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 32. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital