Bispectral Index Monitoring In Pediatric Cataract Surgery: A Comparative Study Using Propofol- Midazolam Versus Sevoflurane Anesthesia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ophthalmic
- Sponsor
- Mansoura University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- assessing depth of anesthesia and its relation to ocular alignment
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Zahraa Ibrahim Zamzm
principal investigator
Mansoura University
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- pupillary dilatation(after insertion of the speculum by 10 minutes and 20 minutes)