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 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT06727435
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-85 years old, with ICU stay \> 24 hours;
* The Richmond Agitation-Sedation Scale (RASS) score is greater than 1 point (Restless: anxious or apprehensive but movements not aggressive or vigorous);
* Patients after neurosurgical craniotomy.
Exclusion Criteria:
* Patients who need deep sedation (PaO2/FiO2≤100 mmHg, loss of consciousness during muscle relaxant therapy, status epilepticus, absolute braking for surgical or surgical conditions, severe traumatic brain injury and cranial hypertension, therapeutic hypothermia and other clinical assessments need to maintain RASS \<-2);
* Patients who may damage the medullary bullongans which contents respiratory center and avoid the application of analgesic drugs;
* Patients who cannot assess the RASS score due to various reasons, such as aphasia, history of mental system (schizophrenia, mania, confusion, history of cognitive dysfunction), generalized seizure status, coma patients, postoperative aphasia, etc.;
* Patients who use sedatives or opioid analgesics ≥ 1 week before enrollment;
* The expected ICU stay time less than 24 hours;
* The patients with delirium, alcohol withdrawal symptoms or mental illness or the use of antipsychotic drugs;
* Severe abnormal liver function (Child-Pugh grade C);
* Renal insufficiency requiring renal replacement therapy;
* Surgical treatment is required during the ICU (except for short surgery, such as lumbar puncture, ventricular drainage, etc.);
* Study drug allergy or other contraindications;
* women during pregnancy or lactation;
* Who was selected in other RCT tests;
* The patient himself or the legally authorized person is not willing to participate in the trial;
* The investigator judged that the patient is not suitable for inclusion (such as severe hypotension; potential disputes, etc.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06727435
Study Brief:
Protocol Section:
NCT06727435