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NCT Number: NCT06690424

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.

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Key information

Conditions

Efficacy and Safety

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Affiliated Hospital of Affiliated Hospital

Nantong, Jiangsu, 226001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: 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.

Other names: P

Primary outcomes

  1. Success rate of induction of anesthesia

    Time frame: At 5 minutes after the onset of anesthesia induction

    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. )

Secondary outcomes

  1. Supplement rate of the study drug

    Time frame: During the operation period

    Number of patients requiring remimazolam supplementation / total number of patients in the experimental group

  2. Sedation depth

    Time frame: 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

    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. )

  3. Amount of sedative and analgesic drugs used

    Time frame: During anesthesia maintenance period

    Amount of sedation and analgesics used per unit time during anesthesia maintenance period

  4. Hemodynamic index （1）

    Time frame: 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

    Heart rate

  5. Hemodynamic index （2）

    Time frame: 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

    mean arterial pressure

Other outcomes

  1. General data of the patient

    Time frame: Before the operation

    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)

  2. Perioperative adverse events

    Time frame: up to 24 hours after surgery

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

  3. Patient satisfaction questionnaire

    Time frame: up to 24 hours after surgery

    The rating scale ranges from levels dissatisfaction, basic satisfaction, satisfaction to very satisfaction, the higher scores mean a better outcome.

  4. Peri-operative-related indicators（1）

    Time frame: up to 6 hours after surgery

    Operation time

  5. Peri-operative-related indicators（2）

    Time frame: up to 6 hours after surgery

    extubation time

  6. Peri-operative-related indicators（3）

    Time frame: up to 6 hours after surgery

    Wake up time

  7. Peri-operative-related indicators（4）

    Time frame: up to 12 hours after surgery

    residence time of Post-anesthesia care unit

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 15, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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