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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07452705
Eligibility Criteria:
Inclusion criteria:
1. Aged \> 10 years old
2. Idiopathic scoliosis scheduled for single-stage posterior spinal fusion (PSF).
3. American Society of Anaesthesiologists (ASA) physical status I-II.
Exclusion criteria:
1. Known hypersensitivity to morphine, ketamine or formulation excipients.
2. Hepatic dysfunction (ALT or AST \> 2 × upper limit of normal).
3. Renal impairment (eGFR ≤ 60 mL min-¹ 1·73 m-²).
4. Uncontrolled asthma or severe restrictive lung disease.
5. Cardiac disease or clinically significant arrhythmia.
6. Epilepsy.
7. Intellectual disability precluding PCA use.
8. Chronic opioid therapy or pre-operative pain \> 3 months.
9. Concomitant monoamine-oxidase inhibitor or tricyclic antidepressant therapy.
10. History of severe postoperative delirium.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT07452705
Study Brief:
Protocol Section:
NCT07452705