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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT04648358
Eligibility Criteria:
Inclusion Criteria:
* scheduled for elective supratentorial craniotomy under general anesthesia;
* age 18 to 64 years;
* an American Society of Anesthesiologists (ASA) physical status of I, II or III;
* preoperative Glasgow Coma Scale (GCS) score of 15/15.
Exclusion Criteria:
* History of chronic headache or chronic pain syndrome of any cause, psychiatric disorders, or uncontrolled epilepsy;
* Inability to understand or use the pain scales before surgery;
* Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 hours before surgery;
* Request of oral/intravenous glucocorticoid to decrease cerebral edema within 1 week before surgery;
* Pregnancy or breastfeeding;
* Extreme body mass index (BMI) (\< 15 or \> 35);
* Participation in another interventional trial that interferes with the intervention or outcome of this trial;
* Refusal or inability of the patient and/or legal guardian to provide informed consent;
* Coagulopathy;
* Infection around the puncture point;
* History of allergies to any of the study drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT04648358
Study Brief:
Protocol Section:
NCT04648358