Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06036095
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2023-04-18
Brief Title:
Total Intravenous Versus Inhalational Anesthesia- A Geriatric Anesthesia Study
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Optimizing Anesthesia to Prevent Postoperative Cognitive and Functional Decline in Older Adults A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
TIVA GAS
Brief Summary:
Traditionally general anesthesia is maintained with inhalational anesthesia GAS but there is a gap in knowledge regarding whether intravenous anesthesia IV can prevent deleterious postoperative outcomes in the geriatric surgical population The goal of this clinical trial is to determine whether intravenous anesthesia IV leads to a decreased incidence of postoperative delirium POD postoperative cognitive dysfunction POCD and functional decline and improved patient-reported outcomes PROs in older adults undergoing non-cardiac surgery when compared to the standard inhalational anesthesia GAS This single-center 11 randomized double-blind patient outcome assessor clinical trial will compare inhalational vs intravenous anesthesia on POD POCD functional status patient-reported outcomes PROs and blood-based biomarkers in older patients undergoing elective inpatient non-cardiac surgery Upon enrollment 260 women and men 70 years undergoing elective noncardiac surgery under general anesthesia will be randomized to 2 groups TIVA or GAS
Detailed Description:
Aim 1 Determine the effects of intravenous vs inhalational anesthesia on incidence of postoperative delirium and postoperative cognitive dysfunction in older adults undergoing non-cardiac surgery
Hypothesis Intravenous anesthesia is associated with a lower incidence of POD and POCD compared to inhalational anesthesia
Primary outcomes Incidence of postoperative delirium and postoperative cognitive dysfunction Secondary outcomes delirium severity delirium duration Aim 2 Determine the effects of intravenous vs inhalational anesthesia on incidence of postoperative functional decline and patient-reported outcomes in older adults undergoing non-cardiac surgery
Hypothesis Intravenous anesthesia is associated with a lower incidence of postoperative functional decline and improved patient-reported outcomes PROs compared to inhalational anesthesia
Primary outcomes Incidence of postoperative functional decline patient-reported outcome scores Aim 3 Determine the effects of intravenous vs inhalational anesthesia on blood phosphorylated tau 181 p-tau181 and other blood biomarkers in older adults undergoing non-cardiac surgery
Hypothesis 1 Elevated preop blood p-tau181 is associated with increased POD and POCD Hypothesis 2 Postoperative increase in blood p-tau181 is greater with GAS relative to IV Hypothesis 3 Postop increases in blood biomarkers of neuroinflammation and AD pathology are greater with GAS relative to IV
Primary outcomes preoperative levels of blood p-tau181 and change in levels from preoperative baseline to postoperative
Secondary outcomes Other candidate biomarkers include those previously implicated in POD or POCD p-tau217 Aβ54 NF-L55 High mobility group box protein 1 HMGB160 S100β76 interleukin IL-658 IL-1β22 IL-1046 tumor necrosis factor TNF-α22 CCL262 and glial fibrillary acidic protein GFAP77
Hypothesis Intravenous anesthesia is associated with a lower incidence of POD and POCD compared to inhalational anesthesia
Primary outcomes Incidence of postoperative delirium and postoperative cognitive dysfunction Secondary outcomes delirium severity delirium duration Aim 2 Determine the effects of intravenous vs inhalational anesthesia on incidence of postoperative functional decline and patient-reported outcomes in older adults undergoing non-cardiac surgery
Hypothesis Intravenous anesthesia is associated with a lower incidence of postoperative functional decline and improved patient-reported outcomes PROs compared to inhalational anesthesia
Primary outcomes Incidence of postoperative functional decline patient-reported outcome scores Aim 3 Determine the effects of intravenous vs inhalational anesthesia on blood phosphorylated tau 181 p-tau181 and other blood biomarkers in older adults undergoing non-cardiac surgery
Hypothesis 1 Elevated preop blood p-tau181 is associated with increased POD and POCD Hypothesis 2 Postoperative increase in blood p-tau181 is greater with GAS relative to IV Hypothesis 3 Postop increases in blood biomarkers of neuroinflammation and AD pathology are greater with GAS relative to IV
Primary outcomes preoperative levels of blood p-tau181 and change in levels from preoperative baseline to postoperative
Secondary outcomes Other candidate biomarkers include those previously implicated in POD or POCD p-tau217 Aβ54 NF-L55 High mobility group box protein 1 HMGB160 S100β76 interleukin IL-658 IL-1β22 IL-1046 tumor necrosis factor TNF-α22 CCL262 and glial fibrillary acidic protein GFAP77
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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