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 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT05117034
Eligibility Criteria:
Inclusion Criteria:
* Informed consent.
* Scheduled for elective craniotomy for resection of supra-tentorial intracranial tumor that requires cranium sawing, dural opening and excision of tumor, under general anesthesia.
* Age 18 - 80 years.
* American Society of Anesthesiologists' physical status I-III.
* Body mass index (BMI) under 35 kg/m2.
Exclusion Criteria:
* Pregnant or current breastfeeding patients.
* Patients unable to provide informed consent or in need of a legal authorized representative.
* Patients with neurological disorders preventing a good understanding of the pain numerical reporting scale (NRS) before surgery.
* Patients with pre-operative aphasia.
* Patients with chronic pain or chronic use of opioids.
* Patients with current alcohol or drug abuse.
* Expected delayed extubation.
* Patients with documented allergy to opioids or acetaminophen.
* Preoperative Glasgow Coma Scale \<15.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05117034
Study Brief:
Protocol Section:
NCT05117034