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 @ 1:30 PM
Ignite Modification Date:
2025-12-24 @ 1:30 PM
NCT ID:
NCT07229495
Eligibility Criteria:
Inclusion Criteria:
* Aged 10 years to less than 18 years.
* Scheduled to undergo posterior spinal fusion (PSF) surgery for scoliosis under general anesthesia.
* American Society of Anesthesiologists (ASA) physical status classification I to III.
* The participant and their parent or legal guardian voluntarily provide written informed consent prior to any study-related procedures.
Exclusion Criteria:
* History of difficult airway, severe respiratory depression (SpO₂ \< 90%), acute or severe bronchial asthma.
* History of severe cardiovascular or cerebrovascular disease, such as myocardial infarction, unstable angina, second-degree or higher atrioventricular block, NYHA Class III or higher heart failure, or stroke.
* Known or suspected gastrointestinal obstruction, including paralytic ileus.
* Known hypersensitivity to opioids or any component of the study drug formulation.
* History of psychiatric disorders (e.g., schizophrenia, depression) or cognitive impairment.
* Diagnosis of neuromuscular scoliosis or presence of any other chronic pain condition that may interfere with postoperative pain assessment.
* Chronic use of opioid analgesics or use of any analgesic medication within 48 hours prior to surgery.
* Planned postoperative admission to the intensive care unit (ICU).
* Any other condition deemed by the investigator to be inappropriate for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
17 Years
Study:
NCT07229495
Study Brief:
Protocol Section:
NCT07229495