Clinical trial NCT06690424: Clinical Studies of the Efficacy and Safety of Remimazolam for Anesthesia Induction and Maintenance in Elderly Patients
Official title: Clinical Studies of the Efficacy and Safety of Remimazolam for Anesthesia Induction and Maintenance in Elderly Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Efficacy and Safety
Keywords: remimazolam
anesthesia induction
continuous anesthesia
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of ureteral stones or renal stones
2. Patients with general anesthesia
3. Patients requiring endotracheal intubation
4. American Society of Anesthesia gradeⅡ to grade Ⅲ
5. age 60-75 years old
6. body mass index was between 18 and 28
7. Patients or their family was clear about the study process and volunteered to participate.

Exclusion Criteria:

1. Patients with known allergy to remimazolam or with previous history of severe allergy and family history
2. Patients with long-term use of narcotic analgesics, sedatives, or non- steroidal anti-inflammatory drugs
3. Patients with drug taking, opioid dependence or tolerance
4. Patients with combined brain injury or intracranial hypertension
5. Patients with severe abnormal function of the heart, lung, liver, kidney and other major organs
6. Patients with bradycardia, with a heart rate lower than 55 beats / minute or a high atrioventricular block
7. Patients with a previous history of allergic disease
8. Patients with a previous history of mental illness
9. Patients with a foreseeable difficult airway
10. The investigator does not consider it appropriate to attend this clinical investigator.

Primary outcomes:
measure: Success rate of induction of anesthesia
timeFrame: At 5 minutes after the onset of anesthesia induction
Secondary outcomes:
measure: Supplement rate of the study drug
timeFrame: During the operation period
measure: Sedation depth
timeFrame: 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
measure: Amount of sedative and analgesic drugs used
timeFrame: During anesthesia maintenance period
measure: Hemodynamic index （1）
timeFrame: 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
measure: Hemodynamic index （2）
timeFrame: 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
Other outcomes:
measure: General data of the patient
timeFrame: Before the operation
measure: Perioperative adverse events
timeFrame: up to 24 hours after surgery
measure: Patient satisfaction questionnaire
timeFrame: up to 24 hours after surgery
measure: Peri-operative-related indicators（1）
timeFrame: up to 6 hours after surgery
measure: Peri-operative-related indicators（2）
timeFrame: up to 6 hours after surgery
measure: Peri-operative-related indicators（3）
timeFrame: up to 6 hours after surgery
measure: Peri-operative-related indicators（4）
timeFrame: up to 12 hours after surgery
Locations:
Study officials:
affiliation: The Affiliated Hospital of Nantong University
name: Xiao MB Director of scientific research Department, Doctor
role: PRINCIPAL_INVESTIGATOR
References: