Clinical Studies of the Efficacy and Safety of Remimazolam for Anesthesia Induction and Maintenance in Elderly Patients

NCT ID: NCT06690424

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-20
• Study Completion Date: 2026-12-31

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.

Conditions

Efficacy and Safety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group R

This group is the experimental group with remimazolam for anesthesia induction and maintenance

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: 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.

group P

This group is the control group with propofol for anesthesia induction and maintenance

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: 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.

Interventions

Remimazolam

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.

Intervention Type: DRUG

Propofol

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.

Intervention Type: DRUG

Other Intervention Names

R; P

Eligibility Criteria

Inclusion Criteria

1. Patients undergoing surgery for clinically diagnosed thyroid tumors

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiao MB Director of scientific research Department, Doctor

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Nantong University

Locations

Affiliated Hospital of Affiliated Hospital

Nantong, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Gao YT Director of the Department of Anesthesiology, Master

Role: CONTACT

gyt19700114@sina.com

+86 13962988003

Liu YF project implementation PI, Master

Role: CONTACT

winters_cool@126.com

+86 13506289927

Other Identifiers

CRCF-YXFN-202401029

Identifier Type: -

Identifier Source: org_study_id