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:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT00675792
Eligibility Criteria:
Inclusion Criteria:
* male or females who are \>= 18 and \<= 65 years of age
* classified by the American Society of Anesthesiologists (ASA) as Class 1 or 2 or 3;
* Body Mass Index (BMI) of \<35 kg/m\^2;
* is scheduled to undergo an elective open abdominal surgical procedure under general anesthesia requiring neuromuscular relaxation using rocuronium bromide (maintenance of neuromuscular blockade if required) for endotracheal intubation and requiring neuromuscular blockade reversal;
* is scheduled to undergo a surgical procedure in a position that does not interfere with the use of TOF-Watch® SX;
* is scheduled to undergo an elective open abdominal procedure expected to last \<=4 hours (from start of skin incision to end of last stitch of the skin);
* have given written informed consent.
Exclusion Criteria:
* participants for whom a difficult intubation is expected because of anatomical malformations;
* is known or suspected to have neuromuscular disorders that may impair neuromuscular blockade;
* is known or suspected to have significant renal dysfunction (e.g., creatinine clearance \< 30 mL/min) ;
* is known or suspected to have significant hepatic dysfunction;
* is known or suspected to have a (family) history of malignant hyperthermia;
* is known or suspected to have an allergy to opioids, muscle relaxants or other medications used during general anesthesia;
* participants for whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
* participants for whom a pre-established need for postoperative intensive care admission is expected;
* pregnant or breast-feeding females;
* have participated in a previous sugammadex clinical trial;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00675792
Study Brief:
Protocol Section:
NCT00675792