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

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.

Study Overview

• Status: Completed
• Conditions: Efficacy and Safety
• Intervention / Treatment: Drug: Remimazolam; Drug: Propofol

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226001
      • Affiliated Hospital of Affiliated Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group R; This group is the experimental group with remimazolam for anesthesia induction and maintenance	Drug: 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.; Other Names: R
Active Comparator: group P; This group is the control group with propofol for anesthesia induction and maintenance	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.; Other Names: P

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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
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. )	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 Outcome Measures

Outcome Measure	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	Incidence of intraoperative awareness, arrhythmia, postoperative delusion, and so on	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
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

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Investigators: Principal Investigator: Xiao MB Director of scientific research Department, Doctor, The Affiliated Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2025
• Primary Completion (Actual): December 30, 2025
• Study Completion (Actual): January 31, 2026

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: remimazolam; anesthesia induction; continuous anesthesia
• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol; remimazolam
• Other Study ID Numbers: CRCF-YXFN-202401029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No