Deep Neuromuscular Block With Pipecuronium in Patients Undergoing Robotic Thoracic Surgery

NCT07868094 | Completed

• 2 other identifiers: AITT2026/37603-2026 RKEB
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patients Undergoing General Anesthesia

Keywords

neuromuscular monitoring; deep neuromuscular blockade; pipecuronium bromide; robot-assisted thoracic surgery

Outcome Measures

Primary Outcomes (1)

• Time from the start of sugammadex administration to achievement of a TOF ratio (TOFR) ≥0.9.

  Time from the start of sugammadex administration to achievement of a TOF ratio (TOFR) ≥0.9.

  Perioperative

Secondary Outcomes (1)

• Time from the start of sugammadex administration to achievement of a TOF ratio (TOFR) = 1.0.

  Perioperative

Other Outcomes (1)

• Quality of the surgeon's visual field during robotic thoracic surgery

  Perioperative

Study Arms (1)

19 surgical patients

undergoing surgical procedures and receiving muscle relaxation

Device: Electromiograph

Interventions

Electromiograph DEVICE

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.

19 surgical patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing robot-aassisted thoracic surgery

You may qualify if:

• adults scheduled for robot-assisted thoracic surgery who, after receiving written informed consent, agreed to participate in the study
• age: 18-85 years;
• ASA 1-3
• procedure requiring endotracheal intubation
• the patient is in the lateral decubitus position and one arm is accessible.

You may not qualify if:

• conditions affecting neuromuscular function (myopathies, severe liver and kidney failure)
• Conditions requiring rapid-sequence intubation (hiatal hernia)
• Medications affecting neuromuscular function (magnesium, aminoglycosides); - anticipated difficult intubation
• Pregnancy
• Breastfeeding

Sponsors & Collaborators

• University of Debrecen: lead

Study Sites (1)

University of Debrecen, Department of Anesthesiology and Intensive Care

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Related Publications (6)

• Tassonyi E, Asztalos L, Szabo-Maak Z, Nemes R, Pongracz A, Lengyel S, Fulesdi B. Reversal of Deep Pipecuronium-Induced Neuromuscular Block With Moderate Versus Standard Dose of Sugammadex: A Randomized, Double-Blind, Noninferiority Trial. Anesth Analg. 2018 Dec;127(6):1344-1350. doi: 10.1213/ANE.0000000000003719.

  PMID: 30169407 BACKGROUND

• Tassonyi E, Pongracz A, Nemes R, Asztalos L, Lengyel S, Fulesdi B. Reversal of Pipecuronium-Induced Moderate Neuromuscular Block with Sugammadex in the Presence of a Sevoflurane Anesthetic: A Randomized Trial. Anesth Analg. 2015 Aug;121(2):373-80. doi: 10.1213/ANE.0000000000000766.

  PMID: 25923435 BACKGROUND

• Fuchs-Buder T, Romero CS, Lewald H, Lamperti M, Afshari A, Hristovska AM, Schmartz D, Hinkelbein J, Longrois D, Popp M, de Boer HD, Sorbello M, Jankovic R, Kranke P. Peri-operative management of neuromuscular blockade: A guideline from the European Society of Anaesthesiology and Intensive Care. Eur J Anaesthesiol. 2023 Feb 1;40(2):82-94. doi: 10.1097/EJA.0000000000001769. Epub 2022 Nov 15.

  PMID: 36377554 BACKGROUND

• Abrishami A, Ho J, Wong J, Yin L, Chung F. Cochrane corner: sugammadex, a selective reversal medication for preventing postoperative residual neuromuscular blockade. Anesth Analg. 2010 Apr 1;110(4):1239. doi: 10.1213/ANE.0b013e3181ce8d5e.

  PMID: 20357160 BACKGROUND

• Takazawa T, Mitsuhata H, Mertes PM. Sugammadex and rocuronium-induced anaphylaxis. J Anesth. 2016 Apr;30(2):290-7. doi: 10.1007/s00540-015-2105-x. Epub 2015 Dec 8.

  PMID: 26646837 BACKGROUND

• Pauli H, Eladawy M, Park J. Anesthesia for robotic thoracic surgery. Ann Cardiothorac Surg. 2019 Mar;8(2):263-268. doi: 10.21037/acs.2018.12.06.

  PMID: 31032211 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiologist and intensive care specialist, PhD

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 9, 2026
• Study Start: March 31, 2026
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

HU (1)