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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT04642651
Eligibility Criteria:
Inclusion Criteria:
* Age ≥65 years but \<90 years;
* Scheduled to undergo unilateral total knee arthroplasty;
* Planned to use femoral nerve block and patient-controlled intravenous analgesia (PCIA) for multimodal analgesia.
Exclusion Criteria:
* Scheduled for bilateral total knee arthroplasty or revision surgery;
* Contraindications to femoral nerve block;
* Preoperative history of schizophrenia, myasthenia gravis, inability to communicate because of coma, severe dementia, or language barriers;
* Preoperative history of hemorrhagic disease or coagulopathy;
* Preoperative obstructive sleep apnea (diagnosed sleep apnea syndrome or a STOP-Bang score ≥3 combined with a serum bicarbonate ≥28 mmol/L);
* Sick sinus syndrome, severe sinus bradycardia (\< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker;
* Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (requirement of renal replacement therapy before surgery), or American Society of Anesthesiologists physical status \>III;
* Preexistent delirium (diagnosed by Three-Dimensional Confusion Assessment Method);
* Under treatment with dexmedetomidine or clonidine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
89 Years
Study:
NCT04642651
Study Brief:
Protocol Section:
NCT04642651