Unlimited
Conditions
Interventions
Elderly patients using remimazolam group:Remimazolam is used in the elderly patients for anesthetic induction and maintenance
Elderly patients using propofol group:Propofol is used in the elderly patients for anesthetic induction and maintenance
Hepatic insufficient patients using remimazolam group:Remimazolam is used in hepatic insufficient patients for anesthetic induction and maintenance
Hepatic insufficient patients using propofol group:Propofol is used in hepatic insufficient patients for anesthetic induction and maintenance
Renal insufficient patients using remimazolam group:Remimazolam is used in renal insufficient patients for anesthetic induction and maintenance
Renal insufficient patients using propofol group:Propofol is used in renal insufficient patients for anesthetic induction and maintenance
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: In first three conditions, subjects can match the only one. 1.Age = 65 years; 2.Chronic hepatic insufficiency: Child-Pugh class B or C (Child-Pugh scale score =7); 3. Chronic renal insufficiency: (glomerular filtration rate(GFR), <90 ml/min) 4.Elective surgeries requiring general anesthesia with artificial airways, with intraoperative Bispectral Index (BIS) monitoring available; 5.Estimated duration of operation = 2 hours, and intraoperative Bispectral Index (BIS) monitoring feasible; 6.Written informed consent provided by legal guardians or patients.
Exclusion criteria
Exclusion criteria: 1.Allergic to investigational drugs; 2.Body Mass Index (BMI): BMI 35 kg/m^2; 3.Pre-existing or anticipated conditions that may significantly affect drug metabolism (including but not limited to: major blood loss, hypothermia, cardiac insufficiency, multi-organ dysfunction, shock, acute deterioration of liver or kidney function, etc.); 4.Requiring continuous sedation and analgesia after surgery; 5.Central nervous system diseases, impaired consciousness, intracranial surgery, surgeries requiring neural stimulation, or discontinuation of intraoperative BIS monitoring; 6.Other conditions as decided by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The quality of induction and maintenance of general anesthesia: the time of maintaining BIS 35~65 divided by the time for test-drug administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and amount of vasoconstrictor agents ;Incidence of hypotension(drug-induced hypotension: SBP 5 min, excluding surgical impacts such as bleeding, cardiovascular compression, allergy);Area under the blood pressure-time curve during drug administration;Time interval between the last discontinuation of test-drug and the first time of opening-eyes;Time interval between the last discontinuation of test-drug and the time of removal of artificial airways;Time interval between the last discontinuation of test-drug and the peaking time for Aldrete scores;Nursing Delirium Screening Scale at discharge from PACU;Incidence of intraoperative awareness;The area under the curve for BIS 65, from the beginning of induction to the end of surgery;Plasma concentration of remimazolam besylate over time;Plasma concentration of remimazolam besylate for BIS 35-65;Incidence of injection pain during induction; | — |
Countries
China
Contacts
Public ContactZhu Tao
West China Hospital, Sichuan University
Outcome results
None listed