This study will be conducted to evaluate effects of different modes of ventilation on pediatric cataract surgery aiming to a peri-operative stable anesthesia, better surgical satisfaction and post operative recovery. It is hypothesized that controlled ventilation without muscle relaxation will be advantageous to other modes in providing adequate surgical satisfaction with considerable depth of anesthesia and better recovery profile.
Anesthetic management in pediatric cataract surgery constitutes a special challenge. Any eye movements can lead to an unsatisfactory surgical field and increase the risk of ophthalmological complications. Achieving adequate ventilation of children is considered another challenge due to huge variability in size and lung maturity. Spontaneous breathing is a popular mode of ventilation with several beneficial effects. Controlled ventilation without muscle relaxation using laryngeal mask airway is attractive option because the side effects of muscle relaxants are avoided. Therefore, this study will be conducted to evaluate effects of different modes of ventilation on pediatric cataract surgery aiming to a peri-operative stable anesthesia, better surgical satisfaction and post-operative recovery. This prospective, randomized, comparative clinical study will include 150 children who will be scheduled for elective cataract surgery under general anesthesia in Mansoura ophthalmology center over one year. Informed written consent will be obtained from parents of all subjects in the study after ensuring confidentiality.The study protocol will be explained to parents of all patients in the study who will be kept fasting prior to surgery. Patients will be randomly assigned to three equal groups according to computer-generated table of random numbers using the permuted block randomization method. In the first group, spontaneous ventilation will be maintained with pressure support; while in the two other groups, mechanical ventilation will be applied with pressure controlled modes. The collected data will be coded, processed, and analyzed using SPSS program. All data will be considered statistically significant if P value is ≤ 0.05.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Ventilator will be adjusted to administer pressure at 10 cmH2O.
Pressure controlled ventilation mode will be applied to obtain a volume of 8 ml/kg up to 20 cmH2O. The set respiratory rate will be 15 breaths/min then it is adjusted to achieve the end tidal CO2 levels between 35 and 40 mmHg as measured by capnography.
Pressure controlled ventilation mode will be applied to obtain a volume of 8 ml/kg up to 20 cmH2O. The set respiratory rate will be 15 breaths/min then it is adjusted to achieve the end tidal CO2 levels between 35 and 40 mmHg as measured by capnography. Also, neuromuscular blockade will be achieved.
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, Egypt
Incidence of eye movements
Incidence any upward or downward deviation of the vision axis during surgery will be recorded
Time frame: Up to the end of the surgery
Changes in intraocular pressure
Intraocular pressure will be measured (mmHg) in the non-operative eye using Schioetz-Tonometer
Time frame: Up to the end of the surgery
Changes in bispectral index
Bispectral index values (0-100) will be recorded every five minutes until the end of the surgery
Time frame: Up to the end of the surgery
Amount of consumption of sevoflurane
Sevoflurane consumption in milliliters will be measured and recorded
Time frame: Up to the end of the surgery
Changes in dynamic compliance
Dynamic compliance (ml /cm H2O) will be recorded after stabilization of ventilation and at the end of surgery
Time frame: Up to the end of the surgery
Changes in heart rate
Heart rate (beat/min) will be recorded at five-minute intervals until the end of the surgery
Time frame: Up to the end of the surgery
Changes in mean arterial blood pressure
Blood pressure (mmHg) will be recorded at five-minute intervals until the end of the surgery
Time frame: Up to the end of the surgery
Value of surgeon satisfaction from the procedure
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Masking
DOUBLE
Enrollment
150
Capnography connected to laryngeal mask airway is introduced after adequate jaw relaxation; its size is chosen according to the body weight of the child.
Sevoflurane in air/oxygen mixture of 40% will be titrated to achieve adequate depth of anesthesia to maintain immobilization of the eye.
The ophthalmogist will be investigated postoperatively for the quality of surgical field (0-8; 0=None, 8=total satisfaction)
Time frame: After the end of the surgery
Improvement in postoperative emergence agitation scale
Agitation will be assessed using the 5- step Cravero scale (1-5) every five minutes from awakening and for 30 minutes. (1:Obtunded with no response to stimulation, 2:Asleep but responsive to movement or stimulation, 3:Awake and responsive, 4:Crying, 5:Thrashing behaviour that requires restraint)
Time frame: Up to 30 minutes after surgery