Active — Not RecruitingPhase 4

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

Hungary80 participantsStarted 2025-06-26

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion Criteria: * 80 adult general surgery, neurosurgery patients were recruited in our study after giving an informed written consent to participate in the studies; * 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 Exclusion Criteria: * 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

What they're measuring

Time till TOF ratio of 0.9

Timeframe: from reversal to extubation

Trial details

NCT IDNCT07044180

SponsorTamas Vegh, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31