Ophthalmic
Conditions
Keywords
propofol, ocular alignment, TIVA
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.
Interventions
OTHERmeasuring 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
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
2 groups, each is 50 child randomly allocated.
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assessing depth of anesthesia and its relation to ocular alignment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pupillary dilatation | after insertion of the speculum by 10 minutes and 20 minutes | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| post emergence agitation | after extubation and for 30 minutes later. | the child will be assessed with Watcha scale. If score is 4 he is considered agitated |
Countries
Egypt
Outcome results
None listed