Patient case: 54-year-old male with malignant hyperthermia; genetic feature: RYR1

Clinical trial: Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Participants Undergoing Short Surgical Procedures (19.4.319)(P05700 AM2)(COMPLETED)

Summary: A multi-center, randomized, parallel group, comparative, active controlled, safety assessor blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine alone in subjects undergoing short surgical procedures in out-patient surgicenters. The primary objective was to evaluate changes in plasma potassium levels after treatment with rocuronium, sugammadex, or succinylcholine in adult subjects scheduled for short surgical procedures in out-patient surgicenters.


Eligibility: Inclusion Criteria:
  -  Male or female subjects >=18 years of age;
  -  ASA Class 1-3;
  -  Subjects with a Body Mass Index (BMI) of < 35 kg/m^2 ;
  -  Subjects scheduled to undergo an elective short procedure with general anesthesia requiring neuromuscular relaxation and endotracheal intubation in outpatient surgicenters;
  -  Subjects scheduled to undergo an elective surgical procedure expected to last 1.5 hours or less (from end of intubation to end of suturing/stapling of skin);
  -  Subjects who are scheduled to undergo an elective surgical procedures that allows access to the arm for TOF-Watch® SX monitoring;
  -  Subjects who have given written informed consent.
  Exclusion Criteria:
  -  Subjects known to have ischemic heart disease or a history of myocardial infarction;
  -  Subjects in whom a difficult intubation is expected because of anatomical malformations;
  -  Subjects with medical conditions and/or undergoing surgical procedures that are not compatible with the use of the TOF-Watch SX (e.g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemakers);
  -  Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis);
  -  Subjects who would require the use of pneumatic tourniquet during the surgical procedure;
  -  Subjects known or suspected to have significant renal dysfunction (e.g., creatinine clearance < 30 mL per min);
  -  Subjects known or suspected to have significant hepatic dysfunction;
  -  Subjects known or suspected to have a (family) history of malignant hyperthermia;
  -  Subjects known or suspected to be hypersensitive to sugammadex or other cyclodextrins or rocuronium or any of its excipients;
  -  Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants, or other medications used during general anesthesia;
  -  Subjects for whom a pre-established need for post operative intensive care admission and/or hospital admission is expected;
  -  Subjects for whom an intra operative IV administration of fluids that contain potassium is expected;
  -  Female subjects who are pregnant;
  -  Female subjects who are breast-feeding;
  -  Subjects who have participated in a previous sugammadex trial;
  -  Subjects who have participated in another investigational drug trial within 30 days before entering into clinical trial (CT) 19.4.319 (P05700) unless pre-approved by the sponsor.

Relevance to patient case: not relevant