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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT01732458
Eligibility Criteria:
Inclusion Criteria:
* Participant enrolled at birth should be at least 37 weeks gestation and ≥3 kg of weight
* Scheduled to receive general anesthesia AND must have at least one of the following risk factors for post-operative nausea and vomiting (PONV) in addition to receiving general anesthesia:
1. scheduled to have a surgery with an associated risk of PONV: tonsillectomy, adenoidectomy, strabismus surgery, dental surgery, hydrocelectomy, orchidopexy or herniorraphy; OR
2. scheduled to have an operative procedure associated with PONV: intraoperative opioid use or anticipated opioid administration within the first 24 hours following surgery.
Exclusion Criteria:
* Emergency surgery for a life-threatening condition
* Scheduled to receive propofol for maintenance of anesthesia (Note: propofol is permitted for induction of anesthesia).
* Expected to receive opioid antagonists (e.g., naloxone, naltrexone) or
benzodiazepine antagonists (e.g., flumazenil)
* Scheduled to undergo cardiac or neurosurgery
* Vomiting caused by any organic etiology (such as gastric outlet
obstruction or small bowel obstruction)
* Vomiting within 24 hours prior to surgery
* Participant had a nasogastric or oral gastric tube intra- or post-operatively for suctioning gastric contents (note: nasogastric or oral gastric tube intra- or post-operatively could only be used for feeding. Participants were to be excluded if a nasogastric or oral gastric tube for suctioning was routinely used for the type of surgery being performed)
* Active infection (e.g., pneumonia), congestive heart failure, bradyarrythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy, or a history of any illness which in the opinion of the investigator, might confound the results of the study or pose unwarranted risk to the participant
* Use of any illicit drugs, including marijuana or has current evidence of alcohol abuse
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT01732458
Study Brief:
Protocol Section:
NCT01732458