Ignite Creation Date:
2024-05-06 @ 2:31 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04341844
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2020-03-31
Brief Title:
Intraoperative Infusion of Methylene Blue for Prevention of Postoperative Delirium and Cognitive Dysfunction in Elderly Patients Undergoing Major Elective Noncardiac Surgery
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Intraoperative Infusion of Methylene Blue for Prevention of Postoperative Delirium and Cognitive Dysfunction in Elderly Patients Undergoing Major Elective Noncardiac and Nonneurosurgical Surgery
Status:
COMPLETED
Status Verified Date:
2020-10
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:
Postoperative neurocognitive impairments often occur in elderly patients undergoing anesthesia and non-cardiac surgery including postoperative delirium POD and postoperative cognitive dysfunction POCD These disorders are often associated with increased mortality and morbidity prolonged length of hospital stay functional and cognitive decline with nursing home or long-term care facility placement Until now highly effective intervention has not been established yet As a mitochondrial protective agent the role of methylene blueMB in preventing elderly patients from PODPOCD is unknownTherefore investigators design this study to validate its prevention against PODPOCD and the aim of this study is to evaluate the efficacy and safety of perioperative administration of MB for PODPOCD prevention
Detailed Description:
Postoperative neurocognitive impairments often occur in elderly patients undergoing major surgery including postoperative deliriumPOD characterized by an acute change in cognition with altered consciousness and impaired attention and postoperative cognitive dysfunctionPOCD mainly manifested as reduced ability of learning and memory POD and POCD are major complications that cause disability and distress for millions of patients annuallyIn 2004 there was an estimated 5-40 incidence in 79 million patients over 65 years who had a surgical procedure subsequently experiencing either POD or POCDThe underlying pathophysiology of Postoperative neurocognitive impairments is increasingly understood implicating a prominent role of neuroinflammation oxidative stress and mitochondrial dysfunctionRecent experimental evidences reveal that mitochondrial dysfunction is increasingly considered a significant contributor to the development of POD and POCD
Methylene blueMB is a diaminophenothiazine with a long history of clinical use due to its minimal side effect profiles MB currently is used for treatment of methemoglobinemia carbon monoxide poisoning and vasoplegic syndrome as well as for surgical staining MB could diffuse rapidly into brain and accumulate in the cytoplasm and mitochondria of neurons In recent years its role as a mitochondrial protective agent has elicited much of its renewed interest especially studies have shown that MB has established its neuroprotective effects against ischemic stroke post-chemotherapy-induced Encephalopathy and neurodegenerative diseases caused by Alzheimers diseaseAD and psychosesTo date there is no trials have examined the role of intraoperative MB administration in prevention of POD and POCD in elderly patients undergoing non-cardiac surgery who have preoperative normal neurocognitive function Therefore investigators design this study to evaluate the efficacy and safety of perioperative administration of MB for PODPOCD prevention Its an entirely novel therapy for postoperative neurocognitive disorders and will have high clinical translatable value if this intervention is found to be beneficial
Methylene blueMB is a diaminophenothiazine with a long history of clinical use due to its minimal side effect profiles MB currently is used for treatment of methemoglobinemia carbon monoxide poisoning and vasoplegic syndrome as well as for surgical staining MB could diffuse rapidly into brain and accumulate in the cytoplasm and mitochondria of neurons In recent years its role as a mitochondrial protective agent has elicited much of its renewed interest especially studies have shown that MB has established its neuroprotective effects against ischemic stroke post-chemotherapy-induced Encephalopathy and neurodegenerative diseases caused by Alzheimers diseaseAD and psychosesTo date there is no trials have examined the role of intraoperative MB administration in prevention of POD and POCD in elderly patients undergoing non-cardiac surgery who have preoperative normal neurocognitive function Therefore investigators design this study to evaluate the efficacy and safety of perioperative administration of MB for PODPOCD prevention Its an entirely novel therapy for postoperative neurocognitive disorders and will have high clinical translatable value if this intervention is found to be beneficial
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