The Dose Range of Remimazolam Besylate in Different Age Groups
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| ClinicalTrials.gov Identifier: NCT06009991 |
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Recruitment Status :
Recruiting
First Posted : August 24, 2023
Last Update Posted : September 6, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Remimazolam Anesthesia | Drug: Remimazolam besylate Drug: Propofol | Not Applicable |
Surgery is an effective method to treat surgical diseases, prolong survival time and improve the quality of life, but patients often face the risk of postoperative complications. In general surgery patients, complications occur in more than 30% of patients. Several observational studies have shown that the severity and duration of intraoperative hypotension are significantly related to the risk of postoperative adverse events such as myocardial injury, renal injury, stroke, delirium, prolonged hospitalization, and death.
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1876 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | The Investigation of the Dose Range of Remimazolam Besylate in Different Age Groups of Adults and Its Effects on Hemodynamics |
| Actual Study Start Date : | July 17, 2023 |
| Estimated Primary Completion Date : | September 30, 2025 |
| Estimated Study Completion Date : | December 31, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Age 45-64
Patients aged 45 to 64 years
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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 |
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Experimental: Age 65-74
Patients aged 65 to 74 years
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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 |
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Experimental: Age 75-84
Patients aged 75 to 84 years
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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 |
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Experimental: Age over 75
Patients aged over 85 years
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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 |
- Occurrence of intraoperative hypotension [ Time Frame: Operation 1 day ]Occurrence of intraoperative hypotension
- Intraoperative dosage of vasoactive drugs [ Time Frame: Operation 1 day ]Intraoperative dosage of vasoactive drugs
- Anesthesia recovery [ Time Frame: Operation 1 day ]Anesthesia recovery
- Cognitive function assessment [ Time Frame: Operation 1 day ]Cognitive function assessment in the anesthesia recovery room
- Major organ complications [ Time Frame: Within 30 days after surgery ]The occurrence of major organ complications within 30 days after surgery
- Hospital stay of patients [ Time Frame: With 30 days after surgery ]Hospital stay of patients
- 30-day mortality after surgery [ Time Frame: 30-day after surgery ]30-day mortality after surgery
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| Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06009991
| Contact: Qiaoqiao Xu | +8618771006963 | qiaoqiaoxu@aliyun.com |
| China, Hubei | |
| ongji Hospital, Tongji Medical College, Huazhong Science and Technology University | Recruiting |
| Wuhan, Hubei, China, 430030 | |
| Contact: Qiaoqiao Xu +8618771006963 qiaoqiaoxu@aliyun.com | |
| Principal Investigator: | Ailin Luo | Tongji Hospital |
| Responsible Party: | Ailin Luo, Professor and Chief Physician, Tongji Hospital |
| ClinicalTrials.gov Identifier: | NCT06009991 |
| Other Study ID Numbers: |
TongjiHospital-Anes QQ02 |
| First Posted: | August 24, 2023 Key Record Dates |
| Last Update Posted: | September 6, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | This is a multicenter clinical study and the plan need depend on multiple hospital views. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Propofol Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs |
Anesthetics, Intravenous Anesthetics, General Anesthetics |