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 @ 1:38 PM
Ignite Modification Date:
2025-12-24 @ 1:38 PM
NCT ID:
NCT00828295
Eligibility Criteria:
MAIN INCLUSION CRITERIA
* Male or female patient aged more than 28 days (full term) up to and including 16 years.
* Inpatient scheduled to undergo surgical procedures requiring general endotracheal anesthesia, including:
* ear, nose and throat surgery;
* eye surgery;
* orchidopexy;
* plastic reconstructive surgery;
* herniorraphy;
* orthopedic surgery).
* American Society of Anesthesiologists (ASA) physical status I, II or III.
* Patient scheduled to receive nitrous oxide during the maintenance phase of anesthesia.
* Patient scheduled to be hospitalized for at least 72 hours after wake up of surgery
* For female of childbearing potential: the patient and her parent(s)/legal guardian(s) were counseled on the importance of not becoming pregnant before or during the study and the patient must have a negative pregnancy test at the pre-treatment visit and at the study treatment visit.
MAIN EXCLUSION CRITERIA
* For infant aged more than 12 months: a history of gastro-esophageal reflux.
* For patient aged 28 days to 6 years: patient who received any investigational drugs within 90 days prior to Day 1. For patient aged 6 up to 16 years inclusive: patient who received any investigational drugs within 30 days prior to Day 1.
* Patient scheduled to undergo emergency surgery.
* Patient scheduled to receive regional (spinal) anesthesia in conjunction with general endotracheal anesthesia.
* Patient scheduled to receive propofol during the maintenance phase of anesthesia.
* Patient with vomiting from any organic cause.
* Any drug with a potential anti-emetic effect within 24 hours prior to the administration of anesthesia.
* Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
28 Days
Maximum Age:
16 Years
Study:
NCT00828295
Study Brief:
Protocol Section:
NCT00828295