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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT01474304
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age
* Weigh at least 50 kg (110.23 lbs)
* Undergoing open, elective intracranial procedure for
* tumor resection
* aneurysm clipping
* revascularization
* Have an ASA (American Society of Anesthesiologists) physical status of 1, 2, 3, or 4
* Able to provide written informed consent
Exclusion Criteria:
* Significant medical disease, laboratory abnormality, or condition that, in the opinion of the investigator, would compromise patient welfare or would otherwise contraindicate study participation
* Unable to communicate symptoms
* Current daily opioid use (\>40 mg morphine equivalent)
* Tramadol use
* Treated with MAO (monoamine oxidase inhibitors) inhibitors within 10 days of surgery
* Treated with any amount of acetaminophen within 8 hours of anesthesia for surgery
* Allergic or hypersensitive to acetaminophen or any contraindications per manufacturer's guidelines
* Pregnancy
* Impaired liver function
* Participation in interventional clinical study within the last 30 days
* Known or suspected history of alcohol or drug abuse
* Surgery for resection of acoustic neuroma
* Transphenoidal tumor resection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01474304
Study Brief:
Protocol Section:
NCT01474304