OphthalmicNCT05262205
Bispectral Index Monitoring In Pediatric Cataract Surgery: A Comparative Study Using Propofol-Midazolam Versus Sevoflurane Anesthesia
A study testing measuring depth of anesthesia and its relation to the globe in people with Ophthalmic, run by Mansoura University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Ophthalmic
- What is being tested?
- measuring depth of anesthesia and its relation to the globe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2021to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 0-children American society of anesthesiologist (ASA )grade l, ll of both sex 0-congenital or traumatic cataract
Who cannot join
- 0- syndromes involving cataract. 0- children with neurologic disorders. 0- children on anti-psychotic medication. 0- hypersensitivity to any anesthetic used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bispectral Index Monitoring In Pediatric Cataract Surgery: A Comparative Study Using Propofol- Midazolam Versus Sevoflurane Anesthesia
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.
Read the detailed description
After signing the informed consent by children parent, child will be transferred to the operating room and will be connected to pulse oximetry, non invasive blood pressure and electrocardiogram(ECG), child will be anesthetized by sevoflurane 8% for cannula insertion, then in Group A, sevoflurane will be continued with 2%, and iv atracurium 0.25mg/kg, and paracetamol 15mg/kg iv will be given. In group B, sevoflurane will be discontinued and propofol bolus1mg/kg iv, midazolam 0.05 mg/kg iv, atracurium 0.25 iv, and paracetamol 15mg/kg iv then propofol infusion will start immediately according to McFarlan protocol for manual syringe pump for pediatrics. For first 10 minutes 15mg/kg, second 10 minutes 13mg/kg, third 10 minutes 13mg/kg, fourth 10 minutes 11mg/kg, fifth 10 minutes 11mg/kg, and will be continued on this rate for the end of surgery. Bispectral index monitor(Covidien, Germany) will be attached to child forehead after cleansing it with alcohol 70%. after adequate jaw relaxation , trachea will be intubated with adequate size endotracheal tube and attached to anesthesia machine ( General electric, Carestation 650).Volume controlled ventilation (VCV) will start with tidal volume(VT) 6-8 ml/kg, respiratory rate (RR)16-20 according to end-tidal carbon dioxide (CO2)35-40mmhg. Flow of fresh gas rate 2 l/minute. standard circuit system connection for pediatric will be used. Heart rate ,peripheral oxygen saturation (SPO2), non invasive blood pressure, end-tidal carbon dioxide (ETCO2), and bispectral index monitor will be measured every 5 minutes. 6 ml/kg of ringer will be given infusion slowly.
- Conditions
- Ophthalmic
- Being tested
- measuring depth of anesthesia and its relation to the globe
- Keywords
- propofol, ocular alignment, TIVA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring depth of anesthesia and its relation to the globeOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: measuring depth of anesthesia and its relation to the globe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: after intubation and every five minutes till end of surgery
Secondary outcomes (1)
pupillary dilatation
pupil of surgical eye is dilated with phenylephrine 2.5%. assessing wether pupillary dilatation will be maintained during anesthesia (> or aqual to 5 mm) or not by using pupil gauge.
Measured: after insertion of the speculum by 10 minutes and 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start15 Nov 2021
- Primary completion14 Aug 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for OphthalmicStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups, each is 50 child randomly allocated.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahraa Ibrahim Zamzm, Mansoura University
- Investigators
- Nabil Abd-Elmagid, professor, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262205
- Sponsor's protocol ID
- MD.21.03.449.R1-2021/04/2021
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12139593Johar 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.
PubMed 15051906Avidan 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.
PubMed 18337600Darlong 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.
PubMed 26240547Degoute 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.
PubMed 11573661Gilbert 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.
PubMed 11285667Kook 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.
PubMed 29770643Pieters 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.
PubMed 20735801Rodgers 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.
PubMed 20393822Rossiter 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.
PubMed 15650757Bajwa 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.
PubMed 20497353Fodale 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.
PubMed 15329609Anderson 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.
PubMed 30920966
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bispectral Index Monitoring In Pediatric Cataract Surgery: A Comparative Study Using Propofol- Midazolam Versus Sevoflurane Anesthesia
- ClinicalTrials.gov ID
- NCT05262205
- Acronym / sponsor ID
- MD.21.03.449.R1-2021/04/2021
- Conditions
- Ophthalmic
- Keywords
- propofol, ocular alignment, TIVA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After signing the informed consent by children parent, child will be transferred to the operating room and will be connected to pulse oximetry, non invasive blood pressure and electrocardiogram(ECG), child will be anesthetized by sevoflurane 8% for cannula insertion, then in Group A, sevoflurane will be continued with 2%, and iv atracurium 0.25mg/kg, and paracetamol 15mg/kg iv will be given. In group B, sevoflurane will be discontinued and propofol bolus1mg/kg iv, midazolam 0.05 mg/kg iv, atracurium 0.25 iv, and paracetamol 15mg/kg iv then propofol infusion will start immediately according to McFarlan protocol for manual syringe pump for pediatrics. For first 10 minutes 15mg/kg, second 10 minutes 13mg/kg, third 10 minutes 13mg/kg, fourth 10 minutes 11mg/kg, fifth 10 minutes 11mg/kg, and will be continued on this rate for the end of surgery. Bispectral index monitor(Covidien, Germany) will be attached to child forehead after cleansing it with alcohol 70%. after adequate jaw relaxation , trachea will be intubated with adequate size endotracheal tube and attached to anesthesia machine ( General electric, Carestation 650).Volume controlled ventilation (VCV) will start with tidal volume(VT) 6-8 ml/kg, respiratory rate (RR)16-20 according to end-tidal carbon dioxide (CO2)35-40mmhg. Flow of fresh gas rate 2 l/minute. standard circuit system connection for pediatric will be used. Heart rate ,peripheral oxygen saturation (SPO2), non invasive blood pressure, end-tidal carbon dioxide (ETCO2), and bispectral index monitor will be measured every 5 minutes. 6 ml/kg of ringer will be given infusion slowly.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups, each is 50 child randomly allocated.
| Arm | Type | Receives |
|---|---|---|
| sevoflurane group with BIS monitor for depth of anesthesia | Active comparator | Other: measuring depth of anesthesia and its relation to the globechild 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). |
| propofol-midazolam group with BIS monitor for depth of anesthesia | Active comparator | Other: measuring depth of anesthesia and its relation to the globeChild 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). |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 0-children American society of anesthesiologist (ASA )grade l, ll of both sex 0-congenital or traumatic cataract
Key exclusion criteria (1 listed)
- 0- syndromes involving cataract. 0- children with neurologic disorders. 0- children on anti-psychotic medication. 0- hypersensitivity to any anesthetic used.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measuring depth of anesthesia and its relation to the globemeasuring 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 | Other | propofol-midazolam group with BIS monitor for depth of anesthesia, sevoflurane group with BIS monitor for depth of anesthesia |
Primary outcome
assessing depth of anesthesia and its relation to ocular alignment
Time frame: after intubation and every five minutes till end of surgery
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
1 secondary outcome
pupillary dilatation
Time frame: after insertion of the speculum by 10 minutes and 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 12139593McCann 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.
- Background: PubMed 15051906Johar 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.
- Background: PubMed 18337600Avidan 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.
- Background: PubMed 26240547Darlong 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.
- Background: PubMed 11573661Degoute 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.
- Background: PubMed 11285667Gilbert 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.
- Background: PubMed 29770643Kook 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.
- Background: PubMed 20735801Pieters 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.
- Background: PubMed 20393822Rodgers 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.
- Background: PubMed 15650757Rossiter 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.
- Background: PubMed 20497353Bajwa 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.
- Background: PubMed 15329609Fodale 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nabil Abd-Elmagid, professor principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measuring depth of anesthesia and its relation to the globe in people with Ophthalmic, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessing depth of anesthesia and its relation to ocular alignment (time frame: after intubation and every five minutes till end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05262205, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.