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 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT07096635
Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing elective unilateral arthroscopic reconstruction of the anterior cruciate ligament (ACL) under spinal anesthesia, aged from 18 to 65 years old, and who are American Society of Anesthesiologists (ASA) physical status I or II of either sex
Exclusion Criteria:
* Contraindications to neuraxial anesthesia (e.g. allergy to local anesthetics, coagulopathies, infection in the area)
* History of cardiovascular, cerebrovascular, respiratory, or psychological disorders
* Chronic pain syndrome and/ or opioid use
* Regular consumption of analgesics, corticosteroids or anticonvulsants
* A known allergy to melatonin
* Patients with diabetes mellitus, sever hypertension, liver or renal dysfunction
* Cognitive disorders (dementia, major depression)
* Circadian rhythm disorders (such as chronic fatigue syndrome and drowsiness)
* Pregnancy/ lactating
* Body mass index 35 kg/m2 or more,
* Patient refusal.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07096635
Study Brief:
Protocol Section:
NCT07096635