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 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT04652427
Eligibility Criteria:
Inclusion Criteria:
* 1\) 18\~65 years old (including 18 and 65 years old), no gender limit;
* 2\) 18 kg/m2 ≤BMI≤30 kg/m2;
* 3\) For patients undergoing elective surgery under non-general anesthesia, the expected duration of surgery is ≥30min;
* 4\) ASA classification is Ⅰ～Ⅲ;
* 5\) After the patient has a full understanding of the purpose and significance of this trial, he/she voluntarily participates in this clinical trial, agrees to contraception during the study period and within 3 days after the study medication, and signs an informed consent Intent.
Exclusion Criteria:
* 1\) Patients who have received anesthesia or surgery within 7 days before randomization;
* 2\) Patients with a history of acute myocardial infarction or unstable angina within 6 months before the screening period;
* 3\) Bradycardia (heart rate \<50 beats/min), Ⅱ or Ⅲ degree atrioventricular block (not including Patients with pacemakers) and other severe arrhythmia and heart failure;
* 4\) Hypertension patients who are not satisfactorily controlled (systolic blood pressure ≥160 mmHg, and/or diastolic blood pressure ≥100 mmHg), or patients with hypotension (systolic blood pressure \<90 mmHg);
* 5\) People with mental system diseases (such as schizophrenia, depression, etc.) or cognitive impairment; Those with a history of epilepsy;
* 6\) Those who suffer from bronchial asthma or other severe respiratory diseases;
* 7\) Abnormal blood coagulation function (PT prolongation exceeds the upper limit of normal for 3 seconds and/or APTT prolongation exceeds. The upper limit of the normal value is 10 seconds);
* 8\) Abnormal liver and kidney function (ALT and/or AST\>2 times the upper limit of normal, total bilirubin\>1.5 Times the upper limit of normal, blood creatinine\>1.5 times the upper limit of normal);
* 9\) Those who have used α2 adrenergic receptor agonists or antagonists within 14 days before randomization;
* 10\) Those who have used sedatives such as benzodiazepines and barbiturates within 7 days before randomization;
* 11\) People with a history of drug abuse, drug abuse and alcohol abuse, among which alcohol abuse is defined as the average daily drinking Liquor exceeds 2 units of alcohol (1 unit = 360 ml of beer or 45 ml of alcohol is 40% white wine or 150 ml wine);
* 12\) Those who are allergic to dexmedetomidine, midazolam, fentanyl and other pharmaceutical ingredients or components;
* 13\) Women who are pregnant or breastfeeding;
* 14\) Those who have participated in other clinical trials within 3 months before randomization;
* 15\) The researcher believes that there are any other circumstances that are not suitable for selection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04652427
Study Brief:
Protocol Section:
NCT04652427