The Dose Range of Remimazolam Besylate in Different Age Groups

NCT06009991 | Unknown DMC

• 1 other identifier: TongjiHospital-Anes QQ02
• Study Type: interventional
• Target: 1,876
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Occurrence of intraoperative hypotension

  Occurrence of intraoperative hypotension

  Operation 1 day

Secondary Outcomes (6)

• Intraoperative dosage of vasoactive drugs

  Operation 1 day

• Anesthesia recovery

  Operation 1 day

• Cognitive function assessment

  Operation 1 day

• Major organ complications

  Within 30 days after surgery

• Hospital stay of patients

  With 30 days after surgery

Study Arms (4)

Age 45-64

EXPERIMENTAL

Patients aged 45 to 64 years

Drug: Remimazolam besylate; Drug: Propofol

Age 65-74

EXPERIMENTAL

Patients aged 65 to 74 years

Drug: Remimazolam besylate; Drug: Propofol

Age 75-84

EXPERIMENTAL

Patients aged 75 to 84 years

Drug: Remimazolam besylate; Drug: Propofol

Age over 75

EXPERIMENTAL

Patients aged over 85 years

Drug: Remimazolam besylate; Drug: Propofol

Interventions

Remimazolam besylate DRUG

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).

Age 45-64; Age 65-74; Age 75-84; Age over 75

Propofol DRUG

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

Age 45-64; Age 65-74; Age 75-84; Age over 75

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age above 45 years old;
• American Society of Anesthesiologists grade Ⅰ-II;
• patients undergoing tracheal intubation or laryngeal mask airway surgery under general anesthesia (intravenous anesthesia);
• Informed consent: patients voluntarily participated in the trial and signed the informed consent form.

You may not qualify if:

• patients with cardiac function grade 3 or above;
• difficult to observe the pupil size of head or neck surgery patients;
• patients with multimodal anesthesia such as nerve block or spinal anesthesia compounded;
• patients known to be allergic to remimazolam besylate or benzodiazepines;
• major vascular surgery and the type of surgery that directly affects hemodynamics;
• patients with coagulation dysfunction, endocrine diseases or other hemodynamic conditions;
• minor surgery (operation duration \<1 hour);
• surgery lasting more than 4 hours;
• emergency surgery;
• patients with a history of drug or alcohol dependence;
• Subjects deemed unsuitable for the study by the investigator.

Sponsors & Collaborators

• Tongji Hospital: lead
• Renmin Hospital of Wuhan University: collaborator
• Wuhan University: collaborator
• The General Hospital of Central Theater Command: collaborator
• Taihe Hospital: collaborator
• Yichang Central People's Hospital: collaborator
• Jingzhou Central Hospital: collaborator
• Beijing Shijitan Hospital, Capital Medical University: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• First Affiliated Hospital of Fujian Medical University: collaborator
• Tianjin Nankai Hospital: collaborator
• Sichuan Provincial People's Hospital: collaborator
• Shanxi Bethune Hospital: collaborator

Study Sites (1)

ongji Hospital, Tongji Medical College, Huazhong Science and Technology University

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (18)

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MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ailin Luo

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiaoqiao Xu

CONTACT

+8618771006963; qiaoqiaoxu@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 24, 2023
• Study Start: July 17, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)