Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04500236
Status:
UNKNOWN
Last Update Posted:
2022-04-22
First Post:
2020-07-22
Brief Title:
Serum Neurofilament Light NFL in Surgery Under General Anaesthesia GA Compared to Surgery With Hypno-analgesia Hyp
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Overview
Official Title:
Release of Serum Neurofilament Light NFL Biomarker of Neuronal Injury in Surgery Under General Anaesthesia GA Compared to Surgery With Hypno-analgesia Hyp A Prospective Non-inferiority Study
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
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:
Experimental studies have shown that inhalational anesthetics may be neurotoxic by for example causing amyloid beta deposition Otherwise a pre-clinical study reported an increase in tau phosphorylation with the use of propofol
Whether anesthesia and surgery contribute to the development of long-term cognitive decline remains however controversial A meta-analysis concluded that general anesthesia could increase the risk of postoperative cognitive decline POCD compared with regional or combined anesthesia but this was not shown for Postoperative delirium POD This conclusion should be interpreted with caution as these studies showed many shortcomings
Currently no study has compared the release of Neurofilament Light a biomarker of neuronal injury in patients undergoing surgery under general anesthesia compared to surgery with Hypno-analgesia and thus without anesthetic drugs
Whether anesthesia and surgery contribute to the development of long-term cognitive decline remains however controversial A meta-analysis concluded that general anesthesia could increase the risk of postoperative cognitive decline POCD compared with regional or combined anesthesia but this was not shown for Postoperative delirium POD This conclusion should be interpreted with caution as these studies showed many shortcomings
Currently no study has compared the release of Neurofilament Light a biomarker of neuronal injury in patients undergoing surgery under general anesthesia compared to surgery with Hypno-analgesia and thus without anesthetic drugs
Detailed Description:
POD and POCD are manifestations of cognitive dysfunction occurring in the perioperative period Whether surgery and specifically anesthesia contribute to the development of perioperative cognitive dysfunctions is not clear
Cell culture and animal studies have suggested detrimental effects of anesthetic exposure123 Otherwise it has been shown in animals that surgery plus anesthesia produced worse POCD than anesthesia alone4 Proinflammatory cytokine levels increase during surgery These elevated levels of inflammatory markers associated with the activation of microglial cells may induce neuroinflammation enhancing ongoing neurodegeneration5 However anesthetics may be capable of modulating inflammation and may alter the neuroinflammatory response
Clinical studies associating the effects of general anesthesia with POCD and POD are conflicting6 These varying results could be due to heterogeneity of patients baseline status eg cognitive status education associated diseases type of surgery as well as methods used to determine POCD and POD
The use of serum neurobiomarkers sensitive and specific for neuronal cell injury will address the hypothesis of general anesthesia neurotoxicity Serum Neurofilament Light NFL is such a neurobiomarkerCurrently no study has compared the release of Neurofilament Light a biomarker of neuronal injury in patients undergoing surgery under general anesthesia compared to surgery with Hypno-analgesia and thus without anesthetic drugs Our hypothesis is that surgery under GA compared to hypnosis does not statistically increase the risk of neuronal injury as measured by serum NFL
Cell culture and animal studies have suggested detrimental effects of anesthetic exposure123 Otherwise it has been shown in animals that surgery plus anesthesia produced worse POCD than anesthesia alone4 Proinflammatory cytokine levels increase during surgery These elevated levels of inflammatory markers associated with the activation of microglial cells may induce neuroinflammation enhancing ongoing neurodegeneration5 However anesthetics may be capable of modulating inflammation and may alter the neuroinflammatory response
Clinical studies associating the effects of general anesthesia with POCD and POD are conflicting6 These varying results could be due to heterogeneity of patients baseline status eg cognitive status education associated diseases type of surgery as well as methods used to determine POCD and POD
The use of serum neurobiomarkers sensitive and specific for neuronal cell injury will address the hypothesis of general anesthesia neurotoxicity Serum Neurofilament Light NFL is such a neurobiomarkerCurrently no study has compared the release of Neurofilament Light a biomarker of neuronal injury in patients undergoing surgery under general anesthesia compared to surgery with Hypno-analgesia and thus without anesthetic drugs Our hypothesis is that surgery under GA compared to hypnosis does not statistically increase the risk of neuronal injury as measured by serum NFL
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