Bladder tumor
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Able to understand and voluntarily sign a written informed consent document; 2. Males between the ages of 18-80 years; 3. Patients scheduled for elective TURBT surgery under general anesthesia; 4. Meet the American Society of Anesthesiologists Physical Condition (ASA) <=II.
Exclusion criteria
Exclusion criteria: 1. Severe hematological, hepatic and renal function abnormalities, consistent with any of the following clinical laboratory test results: 1) Hematology: neutrophil 3 × upper limit of normal (ULN); or total bilirubin (TBIL) >1.5 ×ULN; 3) Renal function: estimated glomerular filtration rate (eGFR) 2×ULN; 2. Have a chronic systemic disease that may affect the subject's participation in the study, including but not limited to: 1) Have severe cardiopulmonary diseases, such as unstable angina, myocardial infarction, severe arrhythmias (such as sinus bradycardia, heart block, and atrial fibrillation), World Health Organization (WHO) cardiac function classification III~IV at screening, hypertension that is still poorly controlled after active treatment, systolic blood pressure > 160mmHg or diastolic blood pressure > at screening 100mmHg; recurrent asthma attacks, etc.; 2) Suffering from chronic digestive diseases, such as liver diseases such as liver fibrosis, recurrent indigestion or diarrhea, peptic ulcers; 3) Neuropsychiatric disorders, including epilepsy, recurrent dizziness, headaches, memory and cognitive impairment; Cerebrovascular accident (such as cerebral infarction) or transient ischemic attack, etc., within 6 months prior to screening; 3. Known history of allergy to the components of the investigational drug or other drugs or excipients with similar chemical structures; 4. Use of dezocin/dexmedetomidine within 4 weeks prior to the start of the screening period; 5. Participated in any other clinical study within 30 days prior to screening; 6. Other conditions judged by the investigator to be unsuitable for participating in this study; 7. Previous use of dezocin/dexmedetomidine and considered to lack efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Moderate to severe CRBD rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The severity of CRBD;Pain Rating: Digital Rating Scale (NRS);Dosage of analgesic drugs;Incidence of CRBD;Other adverse reactions;The patient's satisfaction with this trial;Ramsay calm score; | — |
Countries
China
Contacts
Sun Yat-sen Memorial Hospital, Sun Yat-sen University