Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06009991
Status:
RECRUITING
Last Update Posted:
2023-09-06
First Post:
2023-08-17
Brief Title:
The Dose Range of Remimazolam Besylate in Different Age Groups
Sponsor:
Tongji Hospital
Organization:
Tongji Hospital
Study Overview
Official Title:
The Investigation of the Dose Range of Remimazolam Besylate in Different Age Groups of Adults and Its Effects on Hemodynamics
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None