Myocardial injury
Conditions
Interventions
R1 group:In group R1, remimazolam 1.0 mg· kg-1 · h-1 was intravenously infused
R2 group:In group R2, remimazolam 2.0 mg· kg-1 · h-1 was intravenously infused
R3 group:In group R3, remimazolam 3.0 mg· kg-1 · h-1 was intravenously infused
P group:Propofol 4 mg· kg-1 · h-1 was intravenously infused in group P
Sponsors
The Second People's Hospital of Guiyang
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Any of the following is a "no" and the subject cannot participate in the trial: (1) Healthy male patients, aged 18-65 years, weighing 60-100kg; (2) Body mass index (BMI) : 20-30 kg/m2; (3) Patients undergoing elective gastrointestinal surgery, urological surgery, thoracic surgery, orthopedic limb surgery, orthopedic spine surgery or surface surgery (thyroid or breast surgery), or head and neck surgery under general anesthesia were selected. (4) The duration of operation was not less than 1 hour, not more than 3 hours; (5) American Society of Anesthesiologists (ASA) grade I-III; (6) Patients or their family members agreed and signed the informed consent.
Exclusion criteria
Exclusion criteria: If any of the following is a "yes", the subject cannot participate in the trial: (1) allergic to the active ingredients or excipients of benzodiazepines or flumazenides injection; (2) the presence of any cardiovascular disease known to increase the likelihood of prolongation of the QT interval, abnormal 12-lead electrocardiography, including Fridericia corrected QT interval of 450 ms or more, QRS interval of 110 ms or more, PR of more than 200 ms, and second - or third-degree atrioventricular block; Or any rhythm other than sinus rhythm; (3) Resting heart rate (HR) lower than 50 bpm or higher than 90 bpm; (4) Severe cardiovascular history (congestive heart failure, severe angina pectoris, unstable angina pectoris or myocardial infarction within 6 months) (5) patients expected to be admitted to ICU or return to ward with endotracheal tube after surgery; (6) patients with severe disturbance of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, psychosis, etc.) and cognitive impairment; (7) pregnant or lactating patients; (8) patients with MMSE score < 18; (9) patients with myasthenia gravis or severe depression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of intraoperative arrhythmia was recorded;Ecg QTd;Ecg Tp-Ted;Ecg Tp-Te/QTcv; | — |
Secondary
| Measure | Time frame |
|---|---|
| TNF-a;IL-1ß;IL-6;heart rate;Mean arterial blood pressure;Postoperative nausea and vomiting; | — |
Countries
China
Contacts
Public ContactYing Cao
The Second People's Hospital of Guiyang
Outcome results
None listed