Reversal of Pipecuronium-induced Neuromuscular Blockade With Sugammadex During Sevoflurane Anesthesia

NCT07044193 | Not Yet Recruiting Phase 4 DMC

• 3 other identifiers: AITT 2025/2DE RKEB/IKEB 7108-2025NNGYK/ETGY/08365-4/2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Safety during modern practice of anaesthesia is of great concern. Patients admitted daily for surgical procedures undergoing general anaesthesia for different types of operations are exposed to different risks, starting from the anaesthesia and ending with the surgical intervention. Aim of the study is to provide a comprehensive and evidence based data regarding the safety of the neuromuscular blocking agents used in modern anaesthesia practice, precisely Rocuronium and Pipecuronium, as well as the reversal agents such as Sugammadex, which is the sole agent in use in practice nowadays. A routine anaesthetic practice will be performed during the whole period of our study after strict patient selection criteria. Intraoperative standard monitoring as per local and international guidelines will be applied, this includes Spo2, ECG, NIBP/IBP, etCO2, BIS and Tetragaph for neuromuscular blockade monitoring. After induction of anaesthesia and prior to the administration of the muscle relaxant agent, a TOFC (Train of Four Count) will be registered as the starting point. Throughout the anaesthetic time, there will be continuous TOF monitoring. The anaesthesia will be maintained by sevoflurane. Also, the recruited samples will be divided according to the neuromuscular blockade agents administered, either Rocuronium or Pipecuronium. At the end of the surgical procedure, the time lapse between the administration of the reversal agent Sugammadex and a TOF ratio of 0.9 is registered as our primary end point. TOF measures will be performed in the postoperative period, to make sure there is no residual neuromuscular blockade in the early postoperative phase. The study will not only monitor the safety of the neuromuscular blocking agents in use, but will also monitor any signs of anaphylaxis due to their administration both intra and postoperatively.

Conditions

Neuromuscular Blocking Agents; Residual Neuromuscular Block; Reversal of Neuromuscular Blockade

Keywords

reversal of neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

• Time till TOF ratio of 0.9

  The time between the start of sugammadex administration and reaching a TOF ratio of 0.9 will be the primary efficacy endpoint of the study.

  from reversal to extubation within 5 minutes as per the onset of time of Sugammadex

Secondary Outcomes (1)

• Incidence of residual neuromuscular blockade

  30 minutes after extubation

Other Outcomes (3)

• The incidence of allergic/anaphylactic reactions

  From induction to up to 30 minutes postoperatively

• Time to achieving a TOF ratio of 1.0

  the time elapsed until the onset of Summadex which is within 5 minutes

• Doses of the muscle ralaxants

  from induction to reversal according to the surgical time

Study Arms (2)

Rocuronium bromide as a control muscle relaxant agent in comparison to pipecuronium bromide.

ACTIVE COMPARATOR

Rocuronium bromide induced neuromuscular blockade antagonised by sugammadex as a control.

Drug: Rocuronium bromide

Reversal of pipecuronium induced neuromuscular blockade using sugammadex.

EXPERIMENTAL

Reversal of pipecuronium induced neuromuscular blockade using sugammadex.

Drug: pipecuronium bromide

Interventions

pipecuronium bromide DRUG

Investigation of muscle relaxation with pipecuronium bromide

Reversal of pipecuronium induced neuromuscular blockade using sugammadex.

Rocuronium bromide DRUG

Muscle relaxation with rocuronium as a control

Rocuronium bromide as a control muscle relaxant agent in comparison to pipecuronium bromide.

Eligibility Criteria

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

You may qualify if:

• adult general surgery and neurosurgical patients are enrolled in the study after giving an informed written consent regarding their participation.
• Age: between 18-65 years;
• ASA score: 1-3;
• BMI 18.5-25 (normal body weight);
• Males and females were recruited in an equal ratio;
• Minimal surgical time of at least ≥ 40 minutes;
• Procedures requiring endotracheal intubation;

You may not qualify if:

• Diseases affecting neuromuscular function (myopathies, severe liver and kidney failure);
• Drugs affecting neuromuscular function (magnesium, aminoglycosides);
• Difficult airway, or anticipated difficult intubation;
• Pregnancy (a pregnancy test is performed in women of childbearing age to rule out pregnancy);
• Breast-feeding;
• Acute surgery;
• COPD
• Glaucoma
• History of previous allergic/anaphylactic reactions

Sponsors & Collaborators

• Tamas Vegh, MD: lead

Study Sites (1)

University of Debrecen, Department of Anesthesiology and Intensive Care

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Related Publications (12)

• Naguib M, Brull SJ, Kopman AF, Hunter JM, Fulesdi B, Arkes HR, Elstein A, Todd MM, Johnson KB. Consensus Statement on Perioperative Use of Neuromuscular Monitoring. Anesth Analg. 2018 Jul;127(1):71-80. doi: 10.1213/ANE.0000000000002670.

  PMID: 29200077 BACKGROUND

• Cardona V, Ansotegui IJ, Ebisawa M, El-Gamal Y, Fernandez Rivas M, Fineman S, Geller M, Gonzalez-Estrada A, Greenberger PA, Sanchez Borges M, Senna G, Sheikh A, Tanno LK, Thong BY, Turner PJ, Worm M. World allergy organization anaphylaxis guidance 2020. World Allergy Organ J. 2020 Oct 30;13(10):100472. doi: 10.1016/j.waojou.2020.100472. eCollection 2020 Oct.

  PMID: 33204386 BACKGROUND

• Fuchs-Buder T, Brull SJ, Fagerlund MJ, Renew JR, Cammu G, Murphy GS, Warle M, Vested M, Fulesdi B, Nemes R, Columb MO, Damian D, Davis PJ, Iwasaki H, Eriksson LI. Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents III: The 2023 Geneva revision. Acta Anaesthesiol Scand. 2023 Sep;67(8):994-1017. doi: 10.1111/aas.14279. Epub 2023 Jun 22.

  PMID: 37345870 BACKGROUND

• Samuel WM, Holmes JC. Search for elaphostrongyline parasites in cervids from Alberta. Can J Zool. 1974 Mar;52(3):401-3. doi: 10.1139/z74-048. No abstract available.

  PMID: 4819478 BACKGROUND

• 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

• Pongracz A, Szatmari S, Nemes R, Fulesdi B, Tassonyi E. Reversal of neuromuscular blockade with sugammadex at the reappearance of four twitches to train-of-four stimulation. Anesthesiology. 2013 Jul;119(1):36-42. doi: 10.1097/ALN.0b013e318297ce95.

  PMID: 23665915 BACKGROUND

• Puhringer FK, Gordon M, Demeyer I, Sparr HJ, Ingimarsson J, Klarin B, van Duijnhoven W, Heeringa M. Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship. Br J Anaesth. 2010 Nov;105(5):610-9. doi: 10.1093/bja/aeq226. Epub 2010 Sep 28.

  PMID: 20876699 BACKGROUND

• Duvaldestin P, Kuizenga K, Saldien V, Claudius C, Servin F, Klein J, Debaene B, Heeringa M. A randomized, dose-response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia. Anesth Analg. 2010 Jan 1;110(1):74-82. doi: 10.1213/ANE.0b013e3181c3be3c. Epub 2009 Nov 21.

  PMID: 19933538 BACKGROUND

• Suy K, Morias K, Cammu G, Hans P, van Duijnhoven WG, Heeringa M, Demeyer I. Effective reversal of moderate rocuronium- or vecuronium-induced neuromuscular block with sugammadex, a selective relaxant binding agent. Anesthesiology. 2007 Feb;106(2):283-8. doi: 10.1097/00000542-200702000-00016.

  PMID: 17264722 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

• Kirkegaard H, Heier T, Caldwell JE. Efficacy of tactile-guided reversal from cisatracurium-induced neuromuscular block. Anesthesiology. 2002 Jan;96(1):45-50. doi: 10.1097/00000542-200201000-00013.

  PMID: 11753000 BACKGROUND

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MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Pipecuronium; Rocuronium

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

László Asztalos, MD, PhD

CONTACT

+36307371315; asztaloslasz@gmail.com

Mena Boktor Ajeeb, MD

CONTACT

+36705873304; boktor.mena@med.unideb.hu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Model Details: controlled, randomised

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 29, 2025
• Study Start: June 26, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

HU (1)