The Dose Range of Remimazolam Besylate in Different Age Groups

Summary

This is a multicenter, randomized, parallel, controlled clinical study of patients at different ages underwent elective non-cardiac surgery under general anesthesia. The aim of this study is to explore the dose range of remimazolam besylate for patients at different ages, to provide guidance for anesthesia induction and maintenance of remimazolam besylate. And to investigate the incidence of perioperative hypotension and postoperative related organ dysfunction in patients received total intravenous anesthesia with remimazolam besylate, compared with propofol.

Conditions

• Remimazolam
• Anesthesia

Interventions

DRUG

Remimazolam besylate

Age 45-64: Remimazolam Besylate 0.3 mg/kg for anesthesia induction (0.05mg/kg for additional need) and 0.5mg/kg/h for maintenance (0.25 mg/kg/h for additional need). Age over 65: Remimazolam Besylate 0.15 mg/kg for anesthesia induction (0.05mg/kg for additional need) and 0.5mg/kg/h for maintenance (0.25 mg/kg/h for additional need).

DRUG

Propofol

Age 45-64: Propofol 3.0μg/ml TCI for anesthesia induction and 2.5-3.0μg/ml TCI for maintenance. Age over 65: Propofol 1.5-2.5μg/ml TCI for anesthesia induction and 1.5-2.5μg/ml TCI for maintenance

Sponsors & Collaborators

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Wuhan University

  collaborator OTHER

• The General Hospital of Central Theater Command

  collaborator OTHER

• Taihe Hospital

  collaborator OTHER

• Yichang Central People's Hospital

  collaborator OTHER

• Jingzhou Central Hospital

  collaborator OTHER

• Beijing Shijitan Hospital, Capital Medical University

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Tianjin Nankai Hospital

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

• Shanxi Bethune Hospital

  collaborator OTHER

• Tongji Hospital

  lead OTHER

Principal Investigators

• Ailin Luo · Tongji Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-17

Primary Completion

2025-09-30

Completion

2025-12-31

Countries

• China

Study Locations