None
Conditions
Interventions
ED95 group:According to the sequential method, the initial dose of remidazolam is 0.12mg/kg, and the adjacent gradient is 0.02mg/kg
Propofol induction and maintenance group:Induce propofol 1 mg/kg, maintain propofol 2-4 mg/kg/h
remidazolam induction and maintenance group:Induction of remidazolam 0.2mg/kg, maintenance of remidazolam 0.4-0.8 mg/kg/h
remidazolam combined with propofol induction and maintenance group:Induce propofol 1mg/kg + remidazolam (ED95) and maintain propofol 1mg/kg/h + remidazolam 0.2-0.6 mg/kg/h
Sponsors
Yichang Central People’s Hospital
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: Part I:1. Age: 65-80 years old, gender is not limited, body mass index (BMI): BMI 18-28kg/m^2; 2. American Society of Anesthesiologists (ASA) grade I.-II., Mallampati airway grade I.-II; 3. Patients requiring general anesthesia under endotracheal intubation; 4. Have the ability to act independently, have clear consciousness, and be able to cooperate with the completion of experiments; 5. Respondents agree to participate in the study and sign an informed consent form. Part II:1. Age: 65-80 years old, gender is not limited, body mass index (BMI): BMI 18-28kg/m^2; 2. American Society of Anesthesia (ASA) grade I.~II.; 3. Patients requiring general anesthesia for endotracheal intubation; 4. Patients undergoing posterior cervical/lumbar fusion of 2-3 segments; 5. Have the ability to act independently, have a clear consciousness, and be able to cooperate with the completion of experiments; 6. Respondents agree to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Part I:1. Do not participate in the trial and refuse to sign the informed consent form; 2. ASA classification III.~IV. 3. Patients with severe structural heart disease or arrhythmia; 4. Those with severe cardiovascular and cerebrovascular diseases; 5. Patients with hepatic insufficiency and renal insufficiency (creatinine =133umol/L); 6. Patients who are allergic to the drugs used in the study; 7. Patients with a history of drug abuse or alcoholism, and a history of psychiatric or neurological diseases; 8. Patients with difficult airway or patients with multiple intubation failures. Part II: 1. Do not participate in the trial and refuse to sign the informed consent form; 2. ASA classification III.~IV. 3. Patients with severe structural heart disease or arrhythmia; 4. Those with severe cardiovascular and cerebrovascular diseases; 5. Patients with hepatic insufficiency and renal insufficiency (creatinine =133umol/L); 6. Patients who are allergic to the drugs used in the study; 7. Patients with a history of drug abuse or alcoholism, and a history of psychiatric or neurological diseases; 8. Patients with abnormal thyroid function or patients who are taking cortisol hormone or norepinephrine antagonist/agonist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 95% effective dose of remimazolam for successful intubation sedation (Part I);Time to Consciousness (Part 2);RASS Sedation Agitation Score After Extubation (Part II); | — |
Secondary
| Measure | Time frame |
|---|---|
| Induction systolic blood pressure (Part I);Induction diastolic blood pressure (Part I);Induction Mean Arterial Pressure (Part I);Induction heart rate (Part I);Induction BIS (Part I);BIS<60 Time (Part 1);Frequency and Dosage of Sedative Medication (Part 1);Active Vascular Drug Dosage (Part I);Adverse Events (Part I);Systolic blood pressure during anesthesia (Part II);Diastolic blood pressure during anesthesia (Part II);Mean arterial pressure during anesthesia (Part II);Heart rate during anesthesia (Part II);Time to Extubation (Part 2);PACU Residence Time (Part II);Restlessness during the Awakening Period (Part 2);Immune Indicators at the Beginning and End of Surgery (Part II);Anesthetic Drug Dosage (Part 2);Active Vascular Drug Dosage (Part II);Adverse Events (Part II);Occurrence of cognitive dysfunction on postoperative days 1, 3, and 5 (Part 2);QoR-15 on postoperative days 1, 3, and 5 (Part 2); | — |
Countries
China
Contacts
Public ContactXiaobo Chen
Yichang Central People’s Hospital
Outcome results
None listed