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Recruiting NCT07925463

Comparison of NMTCuff and Standard TOF in Gynecologic Oncology Surgery (NMTCUFF-TOF)

Conditions: Gynecologic Cancer, Neuromuscular Blockade, Residual Neuromuscular Block

Sex: Female
Ages: 18 Years – 75 Years
Healthy volunteers: No
Enrollment: 45
Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Location: Dr. Abdurrahman Yurtarslan Oncology Training and Research Hospital Ankara

Summary

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07925463). StuddyBuddy aggregates publicly available trial information.