A Phase 4 interventional study of Remimazolam and Propofol in Efficacy and Safety, sponsored by Affiliated Hospital of Nantong University. Completed at 1 site in China. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Affiliated Hospital of Nantong University · Phase 4, Interventional, and Treatment
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.
Research background: Rapid and steady anesthesia induction, stable intraoperative circulation, rapid recovery, safe and comfortable, and few adverse reactions are the goals of anesthesiologists. Accelerating the surgical turnover and improving the efficiency are the clinical problems that need to be solved. Clinical general anesthesia often adopts static inhalation compound anesthesia to give full play to the advantages of intravenous and inhalation anesthesia and reduce their respective adverse reactions. Remimazolam, as a new ultra-short-acting benzodiazepine sedative, is not widely used in elderly patients, but its rapid onset, short time half-life, less accumulation, little cardiopulmonary inhibition, no injection pain, and can be antagonized by flumazenil, showing an irreplaceable advantage.
Study objective: To observe the efficacy and safety of remimazolam for the induction and maintenance of anesthesia in elderly patients, and to provide a new option for anesthesia management in elderly and critically ill patients.
Study method: This topic adopts a single-center, prospective, randomized, controlled research method, and expects to include 60 elderly subjects with general endotracheal anesthesia for elective surgery.
Affiliated Hospital of Nantong University is the lead sponsor of 92 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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This group is the experimental group with remimazolam for anesthesia induction and maintenance
Drug: Remimazolam
This group is the control group with propofol for anesthesia induction and maintenance
Drug: Propofol
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.
Also known as: R
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.
Also known as: P
Success rate of induction of anesthesia
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤ 1 point within 5 minutes of administration (The rating scale ranges from levels 0 to 5, and lower MOAA / S score indicates deeper depth of sedation, namely a higher scores mean a worse outcome. )
Time frame: At 5 minutes after the onset of anesthesia induction
Supplement rate of the study drug
Number of patients requiring remimazolam supplementation / total number of patients in the experimental group
Time frame: During the operation period
Sedation depth
the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score at the different time points (The rating scale ranges from levels 0 to 5, and lower MOAA / S score indicates deeper depth of sedation, namely a higher scores mean a worse outcome. )
Time frame: At the beginning of induction (T0); bispectral index at 60 (T1); at 1minute after endotracheal intubation (T2); at surgical skin incision (T3), 30 minutes after the start of surgery(T4), at the end of surgery (T5), and 1minute (T6) after extubation
Amount of sedative and analgesic drugs used
Amount of sedation and analgesics used per unit time during anesthesia maintenance period
Time frame: During anesthesia maintenance period
Hemodynamic index （1）
Heart rate
Time frame: At the beginning of induction (T0); bispectral index at 60 (T1); at 1minute after endotracheal intubation (T2); at surgical skin incision (T3), 30 minutes after the start of surgery(T4), at the end of surgery (T5), and 1minute (T6) after extubation
Hemodynamic index （2）
mean arterial pressure
Time frame: At the beginning of induction (T0); bispectral index at 60 (T1); at 1minute after endotracheal intubation (T2); at surgical skin incision (T3), 30 minutes after the start of surgery(T4), at the end of surgery (T5), and 1minute (T6) after extubation
General data of the patient
Gender, age, height, weight, current medical history, history of combined diseases and medication allergy, history of hypertension / diabetes (maximum hypertension / blood glucose, type and age of medication, and complications of other organs)
Time frame: Before the operation
Perioperative adverse events
Incidence of intraoperative awareness, arrhythmia, postoperative delusion, and so on
Time frame: up to 24 hours after surgery
Patient satisfaction questionnaire
The rating scale ranges from levels dissatisfaction, basic satisfaction, satisfaction to very satisfaction, the higher scores mean a better outcome.
Time frame: up to 24 hours after surgery
Peri-operative-related indicators（1）
Operation time
Time frame: up to 6 hours after surgery
Peri-operative-related indicators（2）
extubation time
Time frame: up to 6 hours after surgery
Peri-operative-related indicators（3）
Wake up time
Time frame: up to 6 hours after surgery
Peri-operative-related indicators（4）
residence time of Post-anesthesia care unit
Time frame: up to 12 hours after surgery
Plan to share: No
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Affiliated Hospital of Nantong University