Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT01440933
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 to 60 years, male.
* American Society of Anesthesiology \[ASA\] status I or II.
* Able to read and understand the information sheet and to sign and date the consent form.
* Scheduled for elective surgery lasting at least 60 minutes under general anaesthesia requiring neuromuscular relaxation using rocuronium bromide for endotracheal intubation.
Exclusion Criteria:
* A history of allergy or hypersensitivity to rocuronium, sugammadex or magnesium
* Neuromuscular disease.
* Preoperative medications known to influence neuromuscular function (for instance, certain antibiotics \[aminoglycosides\] and anticonvulsants \[phenytoine\]).
* Electrolyte abnormalities (for instance, hypermagnaesemia).
* Hepatic dysfunction (i.e bilirubin \<1.5 upper limit normal (ULN), alanine aminotransferase (ALT) \<2.5 x ULN, aspartate aminotransferase (AST) \<2.5 x ULN)
* Renal insufficiency (i.e. Creatinine \<1.5 x ULN, creatinine clearance \<30ml/minute).
* Atrioventricular heart block
* Patients with magnesium treatment
* Patients with a body mass index \<19 or \>28 kg m-2.
* Pregnant, or intending to become pregnant, women.
* Breastfeeding women.
* Expected difficult intubation or mask ventilation.
* Patient having participated in any clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial.
* Patients needing continuous or repeat rocuronium administration for surgical reasons.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01440933
Study Brief:
Protocol Section:
NCT01440933