Clinical trial NCT05262205: Bispectral Index Monitoring In Pediatric Cataract Surgery: A Comparative Study Using Propofol-Midazolam Versus Sevoflurane Anesthesia
Official title: Bispectral Index Monitoring In Pediatric Cataract Surgery: A Comparative Study Using Propofol- Midazolam Versus Sevoflurane Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ophthalmic
Keywords: propofol
ocular alignment
TIVA
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups, each is 50 child randomly allocated.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: assessing depth of anesthesia and its relation to ocular alignment
timeFrame: after intubation and every five minutes till end of surgery
Secondary outcomes:
measure: pupillary dilatation
timeFrame: after insertion of the speculum by 10 minutes and 20 minutes
Other outcomes:
measure: post emergence agitation
timeFrame: after extubation and for 30 minutes later.
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
Study officials:
affiliation: Mansoura University
name: Nabil Abd-Elmagid, professor
role: PRINCIPAL_INVESTIGATOR
References:
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