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 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT01325493
Eligibility Criteria:
Inclusion Criteria:
1. The subject is 10 to 18 years of age
2. The subject's American Society of Anesthesiologists physical status is ASA 1, 2 or 3 (see appendix I)
3. The subject is scheduled for elective posterior spinal fusion and instrumentation.
4. The subject's parent/legally authorized guardian has given written informed consent to participate
Exclusion Criteria:
1. The subject has a history or a family (parent or sibling) history of malignant hyperthermia
2. The subject is pregnant or nursing.
3. The subject has known significant renal disorders determined by medical history, physical examination or laboratory tests
4. The subject has a known or suspected allergy to morphine, remifentanil or ketamine
5. The subject is an ASA classification of 4 or greater (See Appendix I)
6. The subject is scheduled for a surgical sub-procedure (i.e. anterior spinal fusion)
7. The subject is unable to self-administer morphine using patient-controlled analgesia (PCA) pump
8. The subject had a recent opioid exposure (within 1 month of surgery)
9. The subject is obese (body mass index \>30kg/m2)
10. The subject is planned for elective postoperative ventilation
11. The subject has a known ocular disease not permitting pupillometric examination
12. The subject has used any investigation products in the past 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT01325493
Study Brief:
Protocol Section:
NCT01325493