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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT00473694
Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiologists (ASA) Class 1 to 4
* 18 years or older
* Scheduled to undergo an elective surgical procedure under general anesthesia requiring the use of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block
* Scheduled for surgery in supine position
* Given written informed consent
Exclusion Criteria:
* Participants in whom a difficult intubation is expected due to anatomical malformations
* Known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction
* Known or suspected to have a (family) history of malignant hyperthermia
* Known or suspected to have an allergy to narcotics, muscle relaxants, or other medications used during surgery
* Receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics, and magnesium (Mg2+)
* Participants in whom the use of neostigmine and/or glycopyrrolate may be contraindicated
* Female participants who are pregnant or breast-feeding
* Females participants of childbearing potential not using an acceptable method of birth control \[condom or diaphragm with spermicide, vasectomized partner (\> 6 months), IUD, abstinence\]
* Participants who had already participated in an Org 25969 trial
* Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.302
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00473694
Study Brief:
Protocol Section:
NCT00473694