The Dose Range of Remimazolam Besylate in Different Age Groups
NCT ID: NCT06009991
Last Updated: 2023-09-06
Study Results
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Basic Information
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RECRUITING
NA
1876 participants
INTERVENTIONAL
2023-07-17
2025-12-31
Brief Summary
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Detailed Description
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Hypotension, defined as a systolic blood pressure of less than 90 mmHg, a diastolic blood pressure of less than 50 mmHg, or a 20% reduction in systolic blood pressure from baseline, is common during anesthesia and surgery. More than a third of patients receiving propofol sedation experience intraoperative hypotension events, and their duration and degree are associated with harm during surgery.
Remimazolam is a new ultra-short-acting sedative drug developed in recent years, which has a similar structure to midazolam. However, compared with midazolam, remimazolam has the advantages of faster onset, faster recovery, and higher safety. Compared with propofol, remimazolam is noninferior in the success rate of sedation, while the incidence of adverse events such as hypotension is lower. At present, remimazolam has completed phase III clinical studies in many fields, such as colonoscopy, fiberoptic bronchoscopy, and general anesthesia induction and maintenance, which have shown its safety and effectiveness. However, there may be differences in hemodynamics and drug sensitivity among patients of different ages. Compared with young patients, elderly patients have a higher risk of hypotension after anesthesia induction. At present, there is a lack of clinical studies with large samples to clarify the recommended dose of remimazolam for anesthesia induction and maintenance in patients of all ages. The updated instructions for remimazolam besylate for injection on March 28, 2022 also mention that remimazolam besylate is used as a sedative drug for general anesthesia induction and maintenance, and the relevant dose reference is given. However, the safety and effectiveness of patients over 65 years have not been confirmed. The precise regulation of clinical use for patients of different ages and the optimization of drug dosage during anesthesia induction and maintenance are the basis for ensuring the safety of clinical medication at present., in order to maintain the stability of perioperative hemodynamics, and prevent or reduce the occurrence of adverse cardiovascular events.
This study aims to investigate the effect of remimazolam total intravenous anesthesia on intraoperative hemodynamics and the drug requirement for patients of different ages, with propofol as the control, and intraoperative hemodynamics as the main evaluation index, so as to provide evidence for clinical application of remimazolam for elderly patients in anesthesia induction and maintenance.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Age 45-64
Patients aged 45 to 64 years
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).
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
Age 65-74
Patients aged 65 to 74 years
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).
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
Age 75-84
Patients aged 75 to 84 years
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).
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
Age over 75
Patients aged over 85 years
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).
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
Interventions
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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).
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
Eligibility Criteria
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Inclusion Criteria
2. American Society of Anesthesiologists grade Ⅰ-II;
3. patients undergoing tracheal intubation or laryngeal mask airway surgery under general anesthesia (intravenous anesthesia);
4. Informed consent: patients voluntarily participated in the trial and signed the informed consent form.
Exclusion Criteria
2. difficult to observe the pupil size of head or neck surgery patients;
3. patients with multimodal anesthesia such as nerve block or spinal anesthesia compounded;
4. patients known to be allergic to remimazolam besylate or benzodiazepines;
5. major vascular surgery and the type of surgery that directly affects hemodynamics;
6. patients with coagulation dysfunction, endocrine diseases or other hemodynamic conditions;
7. minor surgery (operation duration \<1 hour);
8. surgery lasting more than 4 hours;
9. emergency surgery;
10. patients with a history of drug or alcohol dependence;
11. Subjects deemed unsuitable for the study by the investigator.
45 Years
ALL
No
Sponsors
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Renmin Hospital of Wuhan University
OTHER
Wuhan University
OTHER
The General Hospital of Central Theater Command
OTHER
Taihe Hospital
OTHER
Yichang Central People's Hospital
OTHER
Jingzhou Central Hospital
OTHER
Beijing Shijitan Hospital, Capital Medical University
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
First Affiliated Hospital of Fujian Medical University
OTHER
Tianjin Nankai Hospital
OTHER
Sichuan Provincial People's Hospital
OTHER
Shanxi Bethune Hospital
OTHER
Tongji Hospital
OTHER
Responsible Party
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Ailin Luo
Professor and Chief Physician
Principal Investigators
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Ailin Luo
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Locations
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ongji Hospital, Tongji Medical College, Huazhong Science and Technology University
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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References
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Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
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Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.
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Hallqvist L, Granath F, Fored M, Bell M. Intraoperative Hypotension and Myocardial Infarction Development Among High-Risk Patients Undergoing Noncardiac Surgery: A Nested Case-Control Study. Anesth Analg. 2021 Jul 1;133(1):6-15. doi: 10.1213/ANE.0000000000005391.
Ahuja S, Mascha EJ, Yang D, Maheshwari K, Cohen B, Khanna AK, Ruetzler K, Turan A, Sessler DI. Associations of Intraoperative Radial Arterial Systolic, Diastolic, Mean, and Pulse Pressures with Myocardial and Acute Kidney Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2020 Feb;132(2):291-306. doi: 10.1097/ALN.0000000000003048.
Sneyd JR, Absalom AR, Barends CRM, Jones JB. Hypotension during propofol sedation for colonoscopy: a retrospective exploratory analysis and meta-analysis. Br J Anaesth. 2022 Apr;128(4):610-622. doi: 10.1016/j.bja.2021.10.044. Epub 2021 Dec 13.
Chen SH, Yuan TM, Zhang J, Bai H, Tian M, Pan CX, Bao HG, Jin XJ, Ji FH, Zhong TD, Wang Q, Lv JR, Wang S, Li YJ, Yu YH, Luo AL, Li XK, Min S, Li L, Zou XH, Huang YG. Remimazolam tosilate in upper gastrointestinal endoscopy: A multicenter, randomized, non-inferiority, phase III trial. J Gastroenterol Hepatol. 2021 Feb;36(2):474-481. doi: 10.1111/jgh.15188. Epub 2020 Jul 24.
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Pastis NJ, Yarmus LB, Schippers F, Ostroff R, Chen A, Akulian J, Wahidi M, Shojaee S, Tanner NT, Callahan SP, Feldman G, Lorch DG Jr, Ndukwu I, Pritchett MA, Silvestri GA; PAION Investigators. Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy. Chest. 2019 Jan;155(1):137-146. doi: 10.1016/j.chest.2018.09.015. Epub 2018 Oct 4.
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Other Identifiers
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TongjiHospital-Anes QQ02
Identifier Type: -
Identifier Source: org_study_id
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