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COMPLETED
NCT07868094

Deep Neuromuscular Block With Pipecuronium in Patients Undergoing Robotic Thoracic Surgery

Sponsor: University of Debrecen

View on ClinicalTrials.gov

Summary

Robotic-assisted surgery is rapidly expanding across surgical specialties, including thoracic surgery. Compared with conventional techniques, robotic surgery provides the surgeon with a three-dimensional view and highly precise instrument movement with a 360-degree range of motion. These advantages, however, also place particular emphasis on maintaining complete patient immobility throughout the procedure, as involuntary movement may result in serious injury caused by the robotic instruments. Neuromuscular blockade is therefore an essential component of anesthesia for robot-assisted thoracic surgery. Deep neuromuscular blockade provides profound relaxation of the diaphragm and chest wall muscles, thereby minimizing patient movement and creating optimal surgical conditions. At the same time, prolonged and profound neuromuscular blockade requires accurate quantitative monitoring and reliable pharmacological reversal to ensure safe recovery and facilitate enhanced recovery after surgery (ERAS). Pipecuronium bromide (Arduan®) is a Hungarian-developed, long-acting aminosteroid neuromuscular blocking agent with a duration of approximately 45-100 minutes. It has minimal cardiovascular effects, does not induce histamine release, and is eliminated predominantly through the liver and, to a lesser extent, the kidneys. These pharmacological characteristics make pipecuronium potentially suitable for prolonged surgical procedures. Despite its long duration of action, its use may be compatible with ERAS principles when neuromuscular blockade is continuously and quantitatively monitored and appropriately individualized according to the surgical requirements. In Hungary, pipecuronium is currently the only available long-acting neuromuscular blocking agent. Objective quantitative neuromuscular monitoring is particularly important when long-acting muscle relaxants are used. At our Department of Anesthesiology and Intensive Care, TetraGraph Sensyme monitoring has been routinely implemented in all operating rooms since 2023. This technology enables continuous assessment of the depth of neuromuscular blockade and objective confirmation of recovery of neuromuscular function. An additional advantage of pipecuronium is its ability to be effectively antagonized by sugammadex (Bridion®), a cyclodextrin that encapsulates aminosteroid neuromuscular blocking agents in plasma, thereby rapidly reducing their free concentration and facilitating reversal of neuromuscular blockade. The aim of the present study is to investigate the feasibility of maintaining deep neuromuscular blockade with pipecuronium bromide during robot-assisted thoracic surgery and to evaluate its safe and effective reversal with sugammadex within an ERAS-oriented anesthetic approach. Particular emphasis is placed on continuous quantitative monitoring of deep neuromuscular blockade and objective verification of complete recovery following pharmacological reversal. To our knowledge, the efficacy and safety of pipecuronium-induced deep neuromuscular blockade and its subsequent reversal with sugammadex have not previously been systematically evaluated in the setting of robot-assisted thoracic surgery. The study therefore aims to demonstrate that, despite its long duration of action, pipecuronium can be incorporated into a modern ERAS-compatible anesthetic strategy when the depth of neuromuscular blockade is precisely tailored to surgical requirements and complete reversal is objectively confirmed before emergence from anesthesia.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

19

Start Date

2026-03-31

Completion Date

2026-08-01

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

DEVICE

Electromiograph

Electromyograph measures muscle activity as a summation of the action potentials of muscle fibres. This activity is proportional to the strength of the muscle contraction. The most commonly innervated nerve is also the ulnar nerve, which innervates the abductor digiti minimi and the first dorsalis interosseus muscles. During the measurements, electrical signals from these muscles are detected. EMG has several advantages over other monitoring techniques. It does not require immobilisation of the hand, thumb immobility is not a problem, no preload is required, and hypothermia does not affect the hand as much as other neuromuscular monitors. The TetraGraph (Senzime AB, Sweden) is a portable EMG-based neuromuscular minitor for which the manufacturers received marketing approval from the U.S. Food and Drug Administration (FDA) in 2019.

Locations (1)

University of Debrecen, Department of Anesthesiology and Intensive Care

Debrecen, Hajdú-Bihar, Hungary