A study of remimazolam besylate for general anesthesia and population pharmacokinetics-pharmacodynamics in elderly, hepatic or renal insufficient patients.
- Conditions
- Unlimited
- Registration Number
- ChiCTR2400089033
- Lead Sponsor
- West China Hospital, Sichuan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1.Age = 65 years;<br>2.Elective surgeries requiring general anesthesia with artificial airways, with intraoperative Bispectral Index (BIS) monitoring available;<br>3.Estimated duration of operation = 2 hours, and intraoperative Bispectral Index (BIS) monitoring feasible;<br>4.Written informed consent provided by legal guardians or patients.<br>
1.Allergic to investigational drugs;<br>2.Body Mass Index (BMI): BMI <15 kg/m^2 or > 35 kg/m^2;<br>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.);<br>4.Requiring continuous sedation and analgesia after surgery;<br>5.Central nervous system diseases, impaired consciousness, intracranial surgery, surgeries requiring neural stimulation, or discontinuation of intraoperative BIS monitoring;<br>6.Other conditions as decided by the investigators.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Incidence and amount of vasoconstrictor agents ;Incidence of hypotension(drug-induced hypotension: SBP < 90 mmHg or mean arterial pressure < 60 mmHg, lasting > 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 < 35 and the area above 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;