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

NCT06690424 | Recruiting Phase 4 DMC

• 1 other identifier: CRCF-YXFN-202401029
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Efficacy and Safety

Keywords

remimazolam; anesthesia induction; continuous anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Supplement rate of the study drug

  During the operation period

• Sedation depth

  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

  During anesthesia maintenance period

• Hemodynamic index （1）

  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）

  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 (7)

• General data of the patient

  Before the operation

• Perioperative adverse events

  up to 24 hours after surgery

• Patient satisfaction questionnaire

  up to 24 hours after surgery

Study Arms (2)

group R

EXPERIMENTAL

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

Drug: Remimazolam

group P

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

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.

Also known as: R

group R

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.

Also known as: P

group P

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Affiliated Hospital

Nantong, Jiangsu, 226001, China

RECRUITING

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Xiao MB Director of scientific research Department, Doctor

  The Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao YT Director of the Department of Anesthesiology, Master

CONTACT

+86 13962988003; gyt19700114@sina.com

Liu YF project implementation PI, Master

CONTACT

+86 13506289927; winters_cool@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The enrolled patients and the data collectors were blinded to the grouping status
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 15, 2024
• Study Start: June 20, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 23, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)