Effects of General Anesthesia on Brain FC and Cognition in Children With Potential Neurological Damage

NCT05602311 | Unknown

• 1 other identifier: XH-22-006
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative Cognitive Dysfunction(POCD)is a common postoperative complications, existing clinical research focused on the adult patients, ignoring that the developing human brain with underlying neurological impairments may be at higher risk for cognitive impairment, so we need a prospective study, observe this kind of "special groups" in the brain structure and function of before and after general anesthesia, To determine the susceptibility to neurotoxicity of general anesthesia drugs.

Conditions

Postoperative Cognitive Dysfunction

Keywords

pediatric anesthesia; POCD; fNIRS; functional connectivity

Outcome Measures

Primary Outcomes (2)

• Change in the scores of Wechsler intelligence scale

  The scores of Wechsler intelligence scale before operation and 1 day after operation were compared between the two groups.

  The 1 day before surgery；24 hours after surgery

• The incidence of POCD

  The incidence of POCD was calculated by Z-score method

  up to 24 hours after surgery

Secondary Outcomes (2)

• comparison of functional connectivity

  up to 5 minutes

• Correlation between fNIRS brain function connectivity and cognitive function changes

  one day before surgery and 24 hours after surgery

Study Arms (2)

Group SDB

Children were divided into two groups according to whether they had SDB, group SDB: experimental group (SDB children), group control: control group (typical development children)

Drug: General anesthetic

Group control

Children were divided into two groups according to whether they had SDB, group SDB: experimental group (SDB children), group control: control group (typical development children)

Drug: General anesthetic

Interventions

General anesthetic DRUG

Monitoring the changes of brain functional connectivity and assess cognition in two groups after general anesthesia

Group SDB; Group control

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 4-10 years who planned to undergo surgical treatment or examination under general anesthesia in Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from August 1, 2022 to November 1, 2022 were recruited. Children with SDB who planned to undergo tonsillectomy or adenoidectomy under general anesthesia were selected as the experimental group. According to the age and gender of the children participating in the study, children aged 4-10 years with non-SDB who planned to undergo short surgery under general anesthesia were selected as the control group according to the 1:1 matching principle. Subjects who met the inclusion criteria could enter the study after signing the informed consent form by their legal guardians.

You may qualify if:

• Age 4 to 10 years old, both sexes;
• Apgar score ≥8 at birth;
• ASA (American Society of Anesthesiologists Physical Condition Rating) ⅰ-ⅲ;
• to be treated with SDB under general anesthesia;
• His legal guardian has signed the informed consent -

You may not qualify if:

• Age \< 4 years old; or age \>10 years old;
• suffering from serious heart, lung and brain diseases;
• History of dystocia or perinatal cerebral ischemia and hypoxia;
• Gestational age at birth ≤32 weeks;
• Confirmed or suspected neurological retardation or hearing and vision abnormalities;
• suffering from malignant tumor;
• had received general anesthesia or deep sedation before enrollment

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Department of Anesthesia, Shanghai Xinhua hospital

Shanghai, Shanghai Municipality, 200082, China

RECRUITING

Related Publications (32)

• Deiner S, Silverstein JH. Postoperative delirium and cognitive dysfunction. Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i41-46. doi: 10.1093/bja/aep291.

  PMID: 20007989 BACKGROUND

• Evered LA, Silbert BS. Postoperative Cognitive Dysfunction and Noncardiac Surgery. Anesth Analg. 2018 Aug;127(2):496-505. doi: 10.1213/ANE.0000000000003514.

  PMID: 29889707 BACKGROUND

• Zhang D, Ying J, Ma X, Gao Z, Chen H, Zhu S, Shi L, Lu X. Social Cognitive Dysfunction in Elderly Patients After Anesthesia and Surgery. Front Psychol. 2020 Sep 24;11:541161. doi: 10.3389/fpsyg.2020.541161. eCollection 2020.

  PMID: 33071859 BACKGROUND

• Ehsani R, Djalali Motlagh S, Zaman B, Sehat Kashani S, Ghodraty MR. Effect of General Versus Spinal Anesthesia on Postoperative Delirium and Early Cognitive Dysfunction in Elderly Patients. Anesth Pain Med. 2020 Aug 8;10(4):e101815. doi: 10.5812/aapm.101815. eCollection 2020 Aug.

  PMID: 33134142 BACKGROUND

• Kulason K, Nouchi R, Hoshikawa Y, Noda M, Okada Y, Kawashima R. Indication of Cognitive Change and Associated Risk Factor after Thoracic Surgery in the Elderly: A Pilot Study. Front Aging Neurosci. 2017 Dec 5;9:396. doi: 10.3389/fnagi.2017.00396. eCollection 2017.

  PMID: 29259553 BACKGROUND

• Ikonomidou C, Bosch F, Miksa M, Bittigau P, Vockler J, Dikranian K, Tenkova TI, Stefovska V, Turski L, Olney JW. Blockade of NMDA receptors and apoptotic neurodegeneration in the developing brain. Science. 1999 Jan 1;283(5398):70-4. doi: 10.1126/science.283.5398.70.

  PMID: 9872743 BACKGROUND

• Ji C, Ni Q, Chen W, Yang Z, Ma D. General anesthetic neurotoxicity in the young: Mechanism and prevention. Neurosci Biobehav Rev. 2019 Dec;107:883-896. doi: 10.1016/j.neubiorev.2019.10.003. Epub 2019 Oct 10.

  PMID: 31606415 BACKGROUND

• Amrock LG, Starner ML, Murphy KL, Baxter MG. Long-term effects of single or multiple neonatal sevoflurane exposures on rat hippocampal ultrastructure. Anesthesiology. 2015 Jan;122(1):87-95. doi: 10.1097/ALN.0000000000000477.

  PMID: 25289484 BACKGROUND

• Davidson AJ, Disma N, de Graaff JC, Withington DE, Dorris L, Bell G, Stargatt R, Bellinger DC, Schuster T, Arnup SJ, Hardy P, Hunt RW, Takagi MJ, Giribaldi G, Hartmann PL, Salvo I, Morton NS, von Ungern Sternberg BS, Locatelli BG, Wilton N, Lynn A, Thomas JJ, Polaner D, Bagshaw O, Szmuk P, Absalom AR, Frawley G, Berde C, Ormond GD, Marmor J, McCann ME; GAS consortium. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial. Lancet. 2016 Jan 16;387(10015):239-50. doi: 10.1016/S0140-6736(15)00608-X. Epub 2015 Nov 4.

  PMID: 26507180 BACKGROUND

• McCann ME, de Graaff JC, Dorris L, Disma N, Withington D, Bell G, Grobler A, Stargatt R, Hunt RW, Sheppard SJ, Marmor J, Giribaldi G, Bellinger DC, Hartmann PL, Hardy P, Frawley G, Izzo F, von Ungern Sternberg BS, Lynn A, Wilton N, Mueller M, Polaner DM, Absalom AR, Szmuk P, Morton N, Berde C, Soriano S, Davidson AJ; GAS Consortium. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial. Lancet. 2019 Feb 16;393(10172):664-677. doi: 10.1016/S0140-6736(18)32485-1. Epub 2019 Feb 14.

  PMID: 30782342 BACKGROUND

• Sun LS, Li G, Miller TL, Salorio C, Byrne MW, Bellinger DC, Ing C, Park R, Radcliffe J, Hays SR, DiMaggio CJ, Cooper TJ, Rauh V, Maxwell LG, Youn A, McGowan FX. Association Between a Single General Anesthesia Exposure Before Age 36 Months and Neurocognitive Outcomes in Later Childhood. JAMA. 2016 Jun 7;315(21):2312-20. doi: 10.1001/jama.2016.6967.

  PMID: 27272582 BACKGROUND

• Warner DO, Zaccariello MJ, Katusic SK, Schroeder DR, Hanson AC, Schulte PJ, Buenvenida SL, Gleich SJ, Wilder RT, Sprung J, Hu D, Voigt RG, Paule MG, Chelonis JJ, Flick RP. Neuropsychological and Behavioral Outcomes after Exposure of Young Children to Procedures Requiring General Anesthesia: The Mayo Anesthesia Safety in Kids (MASK) Study. Anesthesiology. 2018 Jul;129(1):89-105. doi: 10.1097/ALN.0000000000002232.

  PMID: 29672337 BACKGROUND

• Zaccariello MJ, Frank RD, Lee M, Kirsch AC, Schroeder DR, Hanson AC, Schulte PJ, Wilder RT, Sprung J, Katusic SK, Flick RP, Warner DO. Patterns of neuropsychological changes after general anaesthesia in young children: secondary analysis of the Mayo Anesthesia Safety in Kids study. Br J Anaesth. 2019 May;122(5):671-681. doi: 10.1016/j.bja.2019.01.022.

  PMID: 30982593 BACKGROUND

• Shi Y, Dykhoff HJ, Guevara LRH, Sangaralingham LR, Schroeder DR, Flick RP, Zaccariello MJ, Warner DO. Moderators of the association between attention-deficit/hyperactivity disorder and exposure to anaesthesia and surgery in children. Br J Anaesth. 2021 Nov;127(5):722-728. doi: 10.1016/j.bja.2021.07.025. Epub 2021 Sep 6.

  PMID: 34503832 BACKGROUND

• Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Sheldon SH, Spruyt K, Ward SD, Lehmann C, Shiffman RN; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):576-84. doi: 10.1542/peds.2012-1671. Epub 2012 Aug 27.

  PMID: 22926173 BACKGROUND

• Lumeng JC, Chervin RD. Epidemiology of pediatric obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):242-52. doi: 10.1513/pats.200708-135MG.

  PMID: 18250218 BACKGROUND

• Katz ES, D'Ambrosio CM. Pathophysiology of pediatric obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):253-62. doi: 10.1513/pats.200707-111MG.

  PMID: 18250219 BACKGROUND

• Buratti L, Viticchi G, Baldinelli S, Falsetti L, Luzzi S, Pulcini A, Petrelli C, Provinciali L, Silvestrini M. Sleep Apnea, Cognitive Profile, and Vascular Changes: An Intriguing Relationship. J Alzheimers Dis. 2017;60(3):1195-1203. doi: 10.3233/JAD-170445.

  PMID: 28984599 BACKGROUND

• Bourke R, Anderson V, Yang JS, Jackman AR, Killedar A, Nixon GM, Davey MJ, Walker AM, Trinder J, Horne RS. Cognitive and academic functions are impaired in children with all severities of sleep-disordered breathing. Sleep Med. 2011 May;12(5):489-96. doi: 10.1016/j.sleep.2010.11.010. Epub 2011 Apr 13.

  PMID: 21493135 BACKGROUND

• Slim M, Westmacott R, Toutounji S, Singh J, Narang I, Weiss S, Krishnan P, Grbac E, Surmava AM, Andres K, MacGregor D, deVeber G, Moharir M, Dlamini N. Obstructive sleep apnea syndrome and neuropsychological function in pediatric stroke. Eur J Paediatr Neurol. 2020 Mar;25:82-89. doi: 10.1016/j.ejpn.2019.11.006. Epub 2019 Nov 21.

  PMID: 31787553 BACKGROUND

• Cha J, Zea-Hernandez JA, Sin S, Graw-Panzer K, Shifteh K, Isasi CR, Wagshul ME, Moran EE, Posner J, Zimmerman ME, Arens R. The Effects of Obstructive Sleep Apnea Syndrome on the Dentate Gyrus and Learning and Memory in Children. J Neurosci. 2017 Apr 19;37(16):4280-4288. doi: 10.1523/JNEUROSCI.3583-16.2017. Epub 2017 Mar 20.

  PMID: 28320844 BACKGROUND

• Zhao J, Han S, Zhang J, Wang G, Wang H, Xu Z, Tai J, Peng X, Guo Y, Liu H, Tian J, Jin X, Zheng L, Zhang J, Ni X. Association between mild or moderate obstructive sleep apnea-hypopnea syndrome and cognitive dysfunction in children. Sleep Med. 2018 Oct;50:132-136. doi: 10.1016/j.sleep.2018.04.009. Epub 2018 Jun 9.

  PMID: 30036785 BACKGROUND

• Daurat A, Sarhane M, Tiberge M. [Obstructive sleep apnea syndrome and cognition: A review]. Neurophysiol Clin. 2016 Jun;46(3):201-15. doi: 10.1016/j.neucli.2016.04.002. Epub 2016 Jun 16. French.

  PMID: 27321089 BACKGROUND

• Strutz P, Tzeng W, Arrington B, Kronzer V, McKinnon S, Ben Abdallah A, Haroutounian S, Avidan MS. Obstructive sleep apnea as an independent predictor of postoperative delirium and pain: protocol for an observational study of a surgical cohort. F1000Res. 2018 Mar 15;7:328. doi: 10.12688/f1000research.14061.2. eCollection 2018.

  PMID: 30026927 BACKGROUND

• Uddin LQ, Dajani DR, Voorhies W, Bednarz H, Kana RK. Progress and roadblocks in the search for brain-based biomarkers of autism and attention-deficit/hyperactivity disorder. Transl Psychiatry. 2017 Aug 22;7(8):e1218. doi: 10.1038/tp.2017.164.

  PMID: 28892073 BACKGROUND

• Guo X, Duan X, Chen H, He C, Xiao J, Han S, Fan YS, Guo J, Chen H. Altered inter- and intrahemispheric functional connectivity dynamics in autistic children. Hum Brain Mapp. 2020 Feb 1;41(2):419-428. doi: 10.1002/hbm.24812. Epub 2019 Oct 10.

  PMID: 31600014 BACKGROUND

• Lin H, Lin Q, Li H, Wang M, Chen H, Liang Y, Bu X, Wang W, Yi Y, Zhao Y, Zhang X, Xie Y, Du S, Yang C, Huang X. Functional Connectivity of Attention-Related Networks in Drug-Naive Children With ADHD. J Atten Disord. 2021 Feb;25(3):377-388. doi: 10.1177/1087054718802017. Epub 2018 Sep 27.

  PMID: 30259777 BACKGROUND

• Li R, Wang L, Chen H, Guo X, Liao W, Tang YL, Chen H. Abnormal dynamics of functional connectivity density in children with benign epilepsy with centrotemporal spikes. Brain Imaging Behav. 2019 Aug;13(4):985-994. doi: 10.1007/s11682-018-9914-0.

  PMID: 29956102 BACKGROUND

• Puglia MP, Vlisides PE, Kaplan CM, Jewell ES, Therrian M, Mashour GA, Li D. Constrained Functional Connectivity Dynamics in Pediatric Surgical Patients Undergoing General Anesthesia. Anesthesiology. 2022 Jul 1;137(1):28-40. doi: 10.1097/ALN.0000000000004221.

  PMID: 35363264 BACKGROUND

• Kline RP, Pirraglia E, Cheng H, De Santi S, Li Y, Haile M, de Leon MJ, Bekker A; Alzheimer's Disease Neuroimaging Initiative. Surgery and brain atrophy in cognitively normal elderly subjects and subjects diagnosed with mild cognitive impairment. Anesthesiology. 2012 Mar;116(3):603-12. doi: 10.1097/ALN.0b013e318246ec0b.

  PMID: 22293721 BACKGROUND

• Tasbihgou SR, Absalom AR. Postoperative neurocognitive disorders. Korean J Anesthesiol. 2021 Feb;74(1):15-22. doi: 10.4097/kja.20294. Epub 2020 Jul 6.

  PMID: 32623846 BACKGROUND

• Evered L, Scott DA, Silbert B, Maruff P. Postoperative cognitive dysfunction is independent of type of surgery and anesthetic. Anesth Analg. 2011 May;112(5):1179-85. doi: 10.1213/ANE.0b013e318215217e. Epub 2011 Apr 7.

  PMID: 21474666 BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Anesthetics, General

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• lai jiang, Dr.

  Xinhua Hospital Affiliated to Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yun wang, Bachelor

CONTACT

17821030239; 1575835421@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of Department of Anesthesia and Critical Care, Xinhua Hospital affiliated to Shanghai Jiao Tong University

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: November 2, 2022
• Study Start: August 15, 2022
• Primary Completion: January 1, 2023
• Study Completion: February 15, 2023
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

CN (1)