Bispectral Index Monitoring In Pediatric Cataract Surgery: A Comparative Study Using Propofol-Midazolam Versus Sevoflurane Anesthesia

NCT05262205 | Completed DMC

• 1 other identifier: MD.21.03.449.R1-2021/04/2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Ocular alignment will be studied in children having cataract surgery that will be divided into two groups, one group will be anesthetized using sevoflurane anesthesia (group A), and the other will be anesthetized by midazolam bolus and propofol infusion (total intravenous anesthesia, TIVA) (group B). in both groups depth of anesthesia will be monitored by bispectral index monitor.

Conditions

Ophthalmic

Keywords

propofol; ocular alignment; TIVA

Outcome Measures

Primary Outcomes (1)

• assessing depth of anesthesia and its relation to ocular alignment

  depth of anesthesia will be measured using bispectral index monitor (BIS) monitor and position of the globe will be assessed and related to it by measuring the angle of deviation in degrees. Then, correlation the findings using pearson correlation co-effecient

  after intubation and every five minutes till end of surgery

Secondary Outcomes (1)

• pupillary dilatation

  after insertion of the speculum by 10 minutes and 20 minutes

Other Outcomes (1)

• post emergence agitation

  after extubation and for 30 minutes later.

Study Arms (2)

sevoflurane group with BIS monitor for depth of anesthesia

ACTIVE COMPARATOR

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).

Other: measuring depth of anesthesia and its relation to the globe

propofol-midazolam group with BIS monitor for depth of anesthesia

ACTIVE COMPARATOR

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).

Other: measuring depth of anesthesia and its relation to the globe

Interventions

measuring depth of anesthesia and its relation to the globe OTHER

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; sevoflurane group with BIS monitor for depth of anesthesia

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children American society of anesthesiologist (ASA )grade l, ll of both sex 0-congenital or traumatic cataract

You may not qualify if:

• syndromes involving cataract. 0- children with neurologic disorders. 0- children on anti-psychotic medication. 0- hypersensitivity to any anesthetic used.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, 35516, Egypt

Location

Related Publications (13)

• 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.

  PMID: 12139593 BACKGROUND

• 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.

  PMID: 15051906 BACKGROUND

• 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.

  PMID: 18337600 BACKGROUND

• 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.

  PMID: 26240547 BACKGROUND

• 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.

  PMID: 11573661 BACKGROUND

• 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.

  PMID: 11285667 BACKGROUND

• 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.

  PMID: 29770643 BACKGROUND

• 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.

  PMID: 20735801 BACKGROUND

• 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.

  PMID: 20393822 BACKGROUND

• 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.

  PMID: 15650757 BACKGROUND

• 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.

  PMID: 20497353 BACKGROUND

• 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.

  PMID: 15329609 BACKGROUND

• 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.

  PMID: 30920966 BACKGROUND

Study Officials

• Nabil Abd-Elmagid, professor

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 2 groups, each is 50 child randomly allocated.

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 2, 2022
• Study Start: November 15, 2021
• Primary Completion: August 14, 2023
• Study Completion: November 15, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)