Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group R | Experimental | This group is the experimental group with remimazolam for anesthesia induction and maintenance |
|
| group P | Active Comparator | This group is the control group with propofol for anesthesia induction and maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. ) | At 5 minutes after the onset of anesthesia induction |
| Measure | Description | Time Frame |
|---|---|---|
| Supplement rate of the study drug | Number of patients requiring remimazolam supplementation / total number of patients in the experimental group | 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. ) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Before the operation |
| Perioperative adverse events |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xiao MB Director of scientific research Department, Doctor | Affiliated Hospital of Nantong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Affiliated Hospital | Nantong | Jiangsu | 226001 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
The enrolled patients and the data collectors were blinded to the grouping status
|
| Propofol | Drug | 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. |
|
|
| 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 | During anesthesia maintenance period |
| Hemodynamic index (1) | Heart rate | 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 | 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 |
Incidence of intraoperative awareness, arrhythmia, postoperative delusion, and so on |
| 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. | up to 24 hours after surgery |
| Peri-operative-related indicators(1) | Operation time | up to 6 hours after surgery |
| Peri-operative-related indicators(2) | extubation time | up to 6 hours after surgery |
| Peri-operative-related indicators(3) | Wake up time | up to 6 hours after surgery |
| Peri-operative-related indicators(4) | residence time of Post-anesthesia care unit | up to 12 hours after surgery |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |