Comparison of NMTCuff and Standard TOF in Gynecologic Oncology Surgery (NMTCUFF-TOF)
Comparison of Neuromuscular Blockade Monitoring Methods in Gynecologic Oncology Surgery: NMTCuff (Vision Duo) Versus Standard Train-of-Four (Acceleromyography)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Özge Cihangir Özek, MD
- Phone Number: 05064969856
- Email: ozgecihangirozek@hotmail.com
Study Contact Backup
- Name: Kamuran Koçyiğit Özer, MD
- Phone Number: 05322082920
- Email: drcandyy@hotmail.com
Study Locations
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Ankara, Turkey (Türkiye)
- Recruiting
- Dr. Abdurrahman Yurtarslan Oncology Training and Research Hospital
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Contact:
- Ozge Cihangir Ozek, MD
- Phone Number: 05064969856
- Email: ozgecihangirozek@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
Description
Inclusion Criteria:
- Patients scheduled for elective laparoscopic gynecologic oncology surgery
- Aged between 18 and 75 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Patients who provide written and verbal informed consent
Exclusion Criteria:
- Known history of neuromuscular disease
- Severe hepatic or renal insufficiency
- Body Mass Index (BMI) greater than 35 kg/m2
- Patient refusal to participate
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Simultaneous Dual NMT Cohort
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Neuromuscular Recovery (TOF Ratio >= 0.90)
Time Frame: From the exact moment of Sugammadex administration up to endotracheal extubation (approximately 10 to 20 minutes).
|
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. |
From the exact moment of Sugammadex administration up to endotracheal extubation (approximately 10 to 20 minutes).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Technical Feasibility and Signal Continuity Under Surgical Drapes
Time Frame: From the initiation of anesthesia monitoring in the operating room until the end of the surgical procedure (up to 4 hours).
|
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. |
From the initiation of anesthesia monitoring in the operating room until the end of the surgical procedure (up to 4 hours).
|
Collaborators and Investigators
Investigators
- Principal Investigator: Özge Cihangir Özek, MD, Abdurrahman YAOTRH
Publications and helpful links
General Publications
- Radkowski P, Baranska A, Mieszkowski M, Dawidowska-Fidrych J, Podhorodecka K. Methods for Clinical Monitoring of Neuromuscular Transmission in Anesthesiology - A Review. Int J Gen Med. 2024 Jan 3;17:9-20. doi: 10.2147/IJGM.S424555. eCollection 2024.
- Rodney G, Raju P, Brull SJ. Neuromuscular block management: evidence-based principles and practice. BJA Educ. 2024 Jan;24(1):13-22. doi: 10.1016/j.bjae.2023.10.005. Epub 2023 Nov 29. No abstract available.
- Radkowski P, Rusc J, Keska M. Comparison of measurements obtained with TOF-Cuff placed on the arm and the TOF-Scan on the adductor pollicis muscle during general anaesthesia using mivacurium: a prospective observational clinical trial. Sci Rep. 2024 Nov 8;14(1):27180. doi: 10.1038/s41598-024-76086-6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-06/129
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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