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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.
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 exposure.1,2,3 Otherwise, it has been shown in animals that surgery plus anesthesia produced worse POCD than anesthesia alone.4 Proinflammatory cytokine levels increase during surgery. These elevated levels of inflammatory markers associated with the activation of microglial cells may induce neuroinflammation enhancing ongoing neurodegeneration.5 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 conflicting.6 These varying results could be due to heterogeneity of patients' baseline status (e.g. 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 neurobiomarker.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. Our hypothesis is that surgery under GA compared to hypnosis does not statistically increase the risk of neuronal injury as measured by serum NFL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Anesthesia (GA) | Active Comparator | Patients undergoing thyroid or breast cancer surgery under general anesthesia |
|
| Hypno-analgesia (Hyp) | Placebo Comparator | Patients undergoing thyroid or breast cancer surgery under Hypno-analgesia; i.e.hypnosis combined with the use of analgesics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General anesthesia | Other | Surgery under general anesthesia with the use of propofol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Neurofilament Light at first postoperative day (18 - 24 hours) postoperatively) between both groups | Comparison of postoperative serum Neurofilament Light between both groups | 18 hours to 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total postoperative analgesic consumption between both groups | Comparison of total consumed analgesics in the postoperative period | 24 hours postoperatively |
| Postoperative C-reactive protein between both groups |
| Measure | Description | Time Frame |
|---|---|---|
| Frontal EEG analysis of patients under hypnosis | Analysis of raw frontal EEG power (in slow, delta, theta, alpha, beta and gamma band) from the depth-of-anesthesia monitor as a sub-analysis of this study | Intraoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mona Momeni, MD, PhD | Contact | 003227647029 | mona.momeni@uclouvain.be |
| Name | Affiliation | Role |
|---|---|---|
| Mona Momeni, MD, PhD | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint Luc | Recruiting | Brussels | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21304998 | Background | Whittington RA, Virag L, Marcouiller F, Papon MA, El Khoury NB, Julien C, Morin F, Emala CW, Planel E. Propofol directly increases tau phosphorylation. PLoS One. 2011 Jan 31;6(1):e16648. doi: 10.1371/journal.pone.0016648. | |
| 15329595 | Background | Eckenhoff RG, Johansson JS, Wei H, Carnini A, Kang B, Wei W, Pidikiti R, Keller JM, Eckenhoff MF. Inhaled anesthetic enhancement of amyloid-beta oligomerization and cytotoxicity. Anesthesiology. 2004 Sep;101(3):703-9. doi: 10.1097/00000542-200409000-00019. |
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All data will be available at the moment of publication of results
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| Hypno-analgesia | Other | Surgery under Hypnosis session and analgesics |
|
Comparison of postoperative highest C-reactive protein between both groups
| 24 hours postoperatively |
| Postoperative serum Neurofilament Light in function of type of surgery | Analysis of postoperative serum Neurofilament Light in function of type of surgery | 24 hours postoperatively |
| Comparison of postoperative Montreal Cognitive Assessment on a scale of 30 (higher scores are better) between both groups | Postoperative Montreal Cognitive Assessment | Day 8 to day 10 |
| Postoperative serum Neurofilament Light at postoperative day 8 - 10 | Analysis of postoperative serum Neurofilament Light between both groups | Day 8 to day 10 |
| Quality of Recovery F15 questionnaire with 15 questions on a scale of 10 (higher scores are better) between both groups | Comparison of quality of recovery between both groups based on a validated questionnaire with 15 items | Day 8 to day 10 |
| 19199872 | Background | Wei H, Xie Z. Anesthesia, calcium homeostasis and Alzheimer's disease. Curr Alzheimer Res. 2009 Feb;6(1):30-5. doi: 10.2174/156720509787313934. |
| 17325501 | Background | Wan Y, Xu J, Ma D, Zeng Y, Cibelli M, Maze M. Postoperative impairment of cognitive function in rats: a possible role for cytokine-mediated inflammation in the hippocampus. Anesthesiology. 2007 Mar;106(3):436-43. doi: 10.1097/00000542-200703000-00007. |
| 24300462 | Background | Riedel B, Browne K, Silbert B. Cerebral protection: inflammation, endothelial dysfunction, and postoperative cognitive dysfunction. Curr Opin Anaesthesiol. 2014 Feb;27(1):89-97. doi: 10.1097/ACO.0000000000000032. |
| 20858956 | Background | Mason SE, Noel-Storr A, Ritchie CW. The impact of general and regional anesthesia on the incidence of post-operative cognitive dysfunction and post-operative delirium: a systematic review with meta-analysis. J Alzheimers Dis. 2010;22 Suppl 3:67-79. doi: 10.3233/JAD-2010-101086. |
| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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