Bispectral Index Monitoring In Pediatric Cataract Surgery: A Comparative Study Using Propofol-Midazolam Versus Sevoflurane Anesthesia
NCT ID: NCT05262205
Last Updated: 2024-02-15
Study Results
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Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2021-11-15
2023-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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sevoflurane group with BIS monitor for depth of anesthesia
child will be anesthetized with sevoflurane 2% and atracurium 0.25mg/kg and paracetamol 15mg/kg, then bispectral index will be recorded after intubation and every five minutes till end of surgery. Position of the globe will recorded every five minutes. Angle of deviation of the globe will be calculated via withdrawing horizontal line passing from the lateral and medial canthi, and another vertical one passing the medial canthus(90-0--90 degree). Bis should be 40-65 to ensure adequate depth of anesthesia. If more than 65 or less than 40, sevoflurane concentration will be adjusted till having the target range. pupillary dilation in surgical eye will be assessed after speculum insertion, 20 minutes after speculum insertion, and before speculum removal by pupil ruler((pupil gauge), whether it will be maintained or not (considered maintained if pupil size equal or more than 5mm).
measuring depth of anesthesia and its relation to the globe
measuring feasibility of BIS monitor in detecting depth of anesthesia in pediatric population and whether it will be beneficial as a tool for helping anesthesiologist in maintaining central globe alignment
propofol-midazolam group with BIS monitor for depth of anesthesia
Child will be anesthetized with midazolam 0.05 mg/kg IV bolus and propofol 1mg/kg IV bolus, paracetamol 15mg\\kg IV infusion, and atracurium 0.25mg/kg IV bolus ,then anesthesia will be maintained with propofol infusion according to Mcfarlan protocol, then BIS will be recorded after intubation and every five minutes till end of surgery. Position of the globe will recorded every five minutes till the end of surgery. Angle of deviation will be calculated in same way as group A. Bis should be 40-65. If more than 65 or less than 40, sevoflurane concentration will be adjusted till having the target range. pupillary dilation in surgical eye will be assessed after speculum insertion, 20 minutes after speculum insertion, and before speculum removal by pupil ruler((pupil gauge) and will be observed all over the surgery with the help of surgeon feedback whether it will be maintained or not (considered maintained if pupil size equal or more than 5mm).
measuring depth of anesthesia and its relation to the globe
measuring feasibility of BIS monitor in detecting depth of anesthesia in pediatric population and whether it will be beneficial as a tool for helping anesthesiologist in maintaining central globe alignment
Interventions
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measuring depth of anesthesia and its relation to the globe
measuring feasibility of BIS monitor in detecting depth of anesthesia in pediatric population and whether it will be beneficial as a tool for helping anesthesiologist in maintaining central globe alignment
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Years
10 Years
ALL
Yes
Sponsors
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Mansoura University
OTHER
Responsible Party
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Zahraa Ibrahim Zamzm
principal investigator
Principal Investigators
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Nabil Abd-Elmagid, professor
Role: PRINCIPAL_INVESTIGATOR
Mansoura University
Locations
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Mansoura university
Al Mansurah, , Egypt
Countries
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References
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McCann ME, Bacsik J, Davidson A, Auble S, Sullivan L, Laussen P. The correlation of bispectral index with endtidal sevoflurane concentration and haemodynamic parameters in preschoolers. Paediatr Anaesth. 2002 Jul;12(6):519-25. doi: 10.1046/j.1460-9592.2002.00886.x.
Johar SR, Savalia NK, Vasavada AR, Gupta PD. Epidemiology based etiological study of pediatric cataract in western India. Indian J Med Sci. 2004 Mar;58(3):115-21.
Avidan MS, Zhang L, Burnside BA, Finkel KJ, Searleman AC, Selvidge JA, Saager L, Turner MS, Rao S, Bottros M, Hantler C, Jacobsohn E, Evers AS. Anesthesia awareness and the bispectral index. N Engl J Med. 2008 Mar 13;358(11):1097-108. doi: 10.1056/NEJMoa0707361.
Darlong V, Garg R, Pandey R, Khokhar S, Chandralekha, Sinha R, Punj J, Sinha R. Evaluation of minimal dose of atracurium for cataract surgery in children: A prospective randomized double-blind study. Saudi J Anaesth. 2015 Jul-Sep;9(3):283-8. doi: 10.4103/1658-354X.154711.
Degoute CS, Macabeo C, Dubreuil C, Duclaux R, Banssillon V. EEG bispectral index and hypnotic component of anaesthesia induced by sevoflurane: comparison between children and adults. Br J Anaesth. 2001 Feb;86(2):209-12. doi: 10.1093/bja/86.2.209.
Gilbert C, Foster A. Childhood blindness in the context of VISION 2020--the right to sight. Bull World Health Organ. 2001;79(3):227-32. Epub 2003 Jul 7.
Kook KH, Chung SA, Park S, Kim DH. Use of the Bispectral Index to Predict Eye Position of Children during General Anesthesia. Korean J Ophthalmol. 2018 Jun;32(3):234-240. doi: 10.3341/kjo.2017.0104. Epub 2018 May 15.
Pieters BJ, Penn E, Nicklaus P, Bruegger D, Mehta B, Weatherly R. Emergence delirium and postoperative pain in children undergoing adenotonsillectomy: a comparison of propofol vs sevoflurane anesthesia. Paediatr Anaesth. 2010 Oct;20(10):944-50. doi: 10.1111/j.1460-9592.2010.03394.x. Epub 2010 Aug 24.
Rodgers A, Cox RG. Anesthetic management for pediatric strabismus surgery: Continuing professional development. Can J Anaesth. 2010 Jun;57(6):602-17. doi: 10.1007/s12630-010-9300-x.
Rossiter JD, Wood M, Lockwood A, Lewis K. Operating conditions for ocular surgery under general anaesthesia: an eccentric problem. Eye (Lond). 2006 Jan;20(1):55-8. doi: 10.1038/sj.eye.6701789.
Bajwa SA, Costi D, Cyna AM. A comparison of emergence delirium scales following general anesthesia in children. Paediatr Anaesth. 2010 Aug;20(8):704-11. doi: 10.1111/j.1460-9592.2010.03328.x.
Fodale V, Pratico C, Santamaria LB. Coadministration of propofol and midazolam decreases bispectral index value as a result of synergic muscle relaxant action on the motor system. Anesthesiology. 2004 Sep;101(3):799; author reply 800-1. doi: 10.1097/00000542-200409000-00033. No abstract available.
Anderson BJ, Bagshaw O. Practicalities of Total Intravenous Anesthesia and Target-controlled Infusion in Children. Anesthesiology. 2019 Jul;131(1):164-185. doi: 10.1097/ALN.0000000000002657.
Study Documents
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Document Type: Study Protocol
View DocumentOther Identifiers
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MD.21.03.449.R1-2021/04/2021
Identifier Type: -
Identifier Source: org_study_id
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