Application of Dexmedetomidine Hydrochloride Injection in Anesthesia for Patients Without Tracheal Intubation

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

With 0.9% sodium chloride injection as a placebo control, to evaluate the effectiveness and safety of dexmedetomidine hydrochloride injection for sedation in patients with non-tracheal intubation

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Treatments: Dexmedetomidine

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.