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The study targets postoperative delirium in patients undergoing major abdominal surgery, with the aim to evaluate the functional baseline and proteomics implicated in pathogenesis, prevention strategies (such as anesthesia depth monitoring) and incidence in certain population groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIS monitoring | Patients in this group will be subjected to Bispectral index-guided general anesthesia. |
| |
| PRST score monitoring | Patients in this group will be subjected PRST score-guided general anesthesia. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIS monitoring | Device | The depth of anesthesia will be monitored using Bispectral Index values. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prediction model for postoperative delirium (POD) in major abdominal surgery | Developing an accesible algorithm to anticipate the occurence of postoperative delirium, based on functional baseline and proteomics, in adult patients subjected to major abdominal surgical interventions. This includes investigating a correlation between a set of risk factors, a panel of biomarkers and the occurrence of postoperative delirium in the enrolled patients, respectively. | 3-4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Anesthesia depth monitoring and the incidence of postoperative delirium | Assessing the influence of BIS monitoring during general anesthesia on the prevalence of postoperative delirium | 0-4 days postoperatively |
| Postoperative delirium incidence in surgical patients in the Intensive Care Unit (ICU) setting |
| Measure | Description | Time Frame |
|---|---|---|
| The influence of POD on length of stay (LOS), unplanned ICU re-admission, cognitive decline and mortality | Evaluating the possibility of a correlation between the occurence of POD and prolonged hospitalization, a prerequisite for ICU re-admittance or further cognitive deterioration / mortality. | during patient hospitalization |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients aged 18 to 70 years, given informed consent, who will be subjected to major abdominal surgery and admitted in the ICU postoperatively, will be assessed from the preoperative period until hospital discharge, to collect the requisite information.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mara Mihaescu, PhD student | Contact | + 40 747540266 | mara.mihaescu05@gmail.com | |
| Daniela Ionescu, MD,PhD | Contact | dionescuati@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Daniela Ionescu, MD, PhD | Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor | Study Director |
| Mara Mihaescu, PhD student | Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Institute of Gastroenterology and Hepatology "Prof.Dr.O.Fodor" | Recruiting | Cluj-Napoca | Cluj | 400162 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31881996 | Background | Belrose JC, Noppens RR. Anesthesiology and cognitive impairment: a narrative review of current clinical literature. BMC Anesthesiol. 2019 Dec 27;19(1):241. doi: 10.1186/s12871-019-0903-7. | |
| 31166241 | Background | Daiello LA, Racine AM, Yun Gou R, Marcantonio ER, Xie Z, Kunze LJ, Vlassakov KV, Inouye SK, Jones RN, Alsop D, Travison T, Arnold S, Cooper Z, Dickerson B, Fong T, Metzger E, Pascual-Leone A, Schmitt EM, Shafi M, Cavallari M, Dai W, Dillon ST, McElhaney J, Guttmann C, Hshieh T, Kuchel G, Libermann T, Ngo L, Press D, Saczynski J, Vasunilashorn S, O'Connor M, Kimchi E, Strauss J, Wong B, Belkin M, Ayres D, Callery M, Pomposelli F, Wright J, Schermerhorn M, Abrantes T, Albuquerque A, Bertrand S, Brown A, Callahan A, D'Aquila M, Dowal S, Fox M, Gallagher J, Anna Gersten R, Hodara A, Helfand B, Inloes J, Kettell J, Kuczmarska A, Nee J, Nemeth E, Ochsner L, Palihnich K, Parisi K, Puelle M, Rastegar S, Vella M, Xu G, Bryan M, Guess J, Enghorn D, Gross A, Gou Y, Habtemariam D, Isaza I, Kosar C, Rockett C, Tommet D, Gruen T, Ross M, Tasker K, Gee J, Kolanowski A, Pisani M, de Rooij S, Rogers S, Studenski S, Stern Y, Whittemore A, Gottlieb G, Orav J, Sperling R; SAGES Study Group*. Postoperative Delirium and Postoperative Cognitive Dysfunction: Overlap and Divergence. Anesthesiology. 2019 Sep;131(3):477-491. doi: 10.1097/ALN.0000000000002729. |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D060825 | Cognitive Dysfunction |
| D057180 | Frontotemporal Dementia |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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venous blood collected for serum analysis of biomarkers
| during ICU hospitalization |
| Postoperative delirium incidence in surgical patients - subgroup - communism survivors | during ICU hospitalization |
| Postoperative delirium incidence in surgical patients - subgroup - patients with no relatives/visitors | during ICU hospitalization |
| 31897646 | Background | Lee SH, Lim SW. Risk factors for postoperative delirium after colorectal surgery: a systematic review and meta-analysis. Int J Colorectal Dis. 2020 Mar;35(3):433-444. doi: 10.1007/s00384-019-03498-6. Epub 2020 Jan 2. |
| 28608014 | Background | Park SA, Tomimaru Y, Shibata A, Miyagawa S, Noguchi K, Dono K. Incidence and Risk Factors for Postoperative Delirium in Patients After Hepatectomy. World J Surg. 2017 Nov;41(11):2847-2853. doi: 10.1007/s00268-017-4079-3. |
| 29656802 | Background | Saxena S, Maze M. Impact on the brain of the inflammatory response to surgery. Presse Med. 2018 Apr;47(4 Pt 2):e73-e81. doi: 10.1016/j.lpm.2018.03.011. Epub 2018 Apr 12. |
| 28504118 | Background | Inoue R, Sumitani M, Ogata T, Chikuda H, Matsubara T, Kato S, Shimojo N, Uchida K, Yamada Y. Direct evidence of central nervous system axonal damage in patients with postoperative delirium: A preliminary study of pNF-H as a promising serum biomarker. Neurosci Lett. 2017 Jul 13;653:39-44. doi: 10.1016/j.neulet.2017.05.023. Epub 2017 May 11. |
| 30348620 | Background | Alam A, Hana Z, Jin Z, Suen KC, Ma D. Surgery, neuroinflammation and cognitive impairment. EBioMedicine. 2018 Nov;37:547-556. doi: 10.1016/j.ebiom.2018.10.021. Epub 2018 Oct 19. |
| 34465469 | Background | Evered LA, Chan MTV, Han R, Chu MHM, Cheng BP, Scott DA, Pryor KO, Sessler DI, Veselis R, Frampton C, Sumner M, Ayeni A, Myles PS, Campbell D, Leslie K, Short TG. Anaesthetic depth and delirium after major surgery: a randomised clinical trial. Br J Anaesth. 2021 Nov;127(5):704-712. doi: 10.1016/j.bja.2021.07.021. Epub 2021 Aug 28. |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D057174 | Frontotemporal Lobar Degeneration |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D057177 | TDP-43 Proteinopathies |
| D019636 | Neurodegenerative Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |