Clinical Studies of the Efficacy and Safety of Remimazolam for Anesthesia Induction and Maintenance in Elderly Patients
Affiliated Hospital of Nantong University
60 participants
Jun 20, 2025
INTERVENTIONAL
Conditions
Summary
the investigators are conducting a clinical study on the efficacy and safety of remimazolam for induction and maintenance of anesthesia in elderly patients. Project number: CRCF-YXFN-202401029, funded by the Red Cross Foundation of China and will take more than 2 years to complete. This is a single-center, randomized, controlled clinical study, randomized 60 elderly subjects undergoing general anesthesia for elective surgery. According to the random number method, propofol group (control group, group P) and remimazolam group (experimental group, group R), 30 cases in each group. By participating in this study, it is possible to make anesthesia induction rapid and stable, stable intraoperative circulation, rapid recovery and safe and comfortable, reduce the Incidence of intraoperative awareness, arrhythmia, postoperative delusion, and so on, which is conducive to rapid postoperative recovery and reduce hospitalization costs.
Eligibility
Inclusion Criteria7
- Patients undergoing surgery for clinically diagnosed thyroid tumors
- Patients with general anesthesia
- Patients requiring endotracheal intubation
- American Society of Anesthesia gradeⅡ to grade Ⅲ
- age 60-75 years old
- body mass index was between 18 and 28
- Patients or their family was clear about the study process and volunteered to participate.
Exclusion Criteria10
- Patients with known allergy to remimazolam or with previous history of severe allergy and family history
- Patients with long-term use of narcotic analgesics, sedatives, or non- steroidal anti-inflammatory drugs
- Patients with drug taking, opioid dependence or tolerance
- Patients with combined brain injury or intracranial hypertension
- Patients with severe abnormal function of the heart, lung, liver, kidney and other major organs
- Patients with bradycardia, with a heart rate lower than 55 beats / minute or a high atrioventricular block
- Patients with a previous history of allergic disease
- Patients with a previous history of mental illness
- Patients with a foreseeable difficult airway
- The investigator does not consider it appropriate to attend this clinical investigator.
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Interventions
remimazolam 0.2mg / kg was injected IV during the induction of anesthesia，and remimazolam 0.3-0.5mg / kg / h was administered IV during anesthesia maintenance.
Propofol 1.5-2mg / kg was injected IV during the induction of anesthesia，and Propofol 2-3mg / kg / h was administered IV during anesthesia maintenance.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06690424