Cataract Surgery, Laryngeal Mask Airway, Ventilation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREUnparalyzed Pressure Control Ventilation
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.
PROCEDUREPressure Support Ventilation
Ventilator will be adjusted to administer pressure at 10 cmH2O.
PROCEDUREParalyzed Pressure Control Ventilation
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.
DEVICELaryngeal Mask Airway
Capnography connected to laryngeal mask airway is introduced after adequate jaw relaxation; its size is chosen according to the body weight of the child.
DRUGSevoflurane
Sevoflurane in air/oxygen mixture of 40% will be titrated to achieve adequate depth of anesthesia to maintain immobilization of the eye.
Sponsors
Sameh Fathy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiology (ASA) I and II patients. * Scheduled for elective cataract surgery.
Exclusion criteria
* Parental refusal of consent. * Contraindication to use of supraglottic airway device as gastroesophageal reflux and oropharyngeal pathology. * Hyperactive airway disease or respiratory diseases. * Children with developmental delays, mental or neurological disorders. * Bleeding or coagulation diathesis. * History of known sensitivity to the used anesthetics. * Previous surgery in the same eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of eye movements | Up to the end of the surgery | Incidence any upward or downward deviation of the vision axis during surgery will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in bispectral index | Up to the end of the surgery | Bispectral index values (0-100) will be recorded every five minutes until the end of the surgery |
| Amount of consumption of sevoflurane | Up to the end of the surgery | Sevoflurane consumption in milliliters will be measured and recorded |
| Changes in dynamic compliance | Up to the end of the surgery | Dynamic compliance (ml /cm H2O) will be recorded after stabilization of ventilation and at the end of surgery |
| Changes in intraocular pressure | Up to the end of the surgery | Intraocular pressure will be measured (mmHg) in the non-operative eye using Schioetz-Tonometer |
| Changes in mean arterial blood pressure | Up to the end of the surgery | Blood pressure (mmHg) will be recorded at five-minute intervals until the end of the surgery |
| Value of surgeon satisfaction from the procedure | After the end of the surgery | The ophthalmogist will be investigated postoperatively for the quality of surgical field (0-8; 0=None, 8=total satisfaction) |
| Improvement in postoperative emergence agitation scale | Up to 30 minutes after surgery | 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) |
| Changes in heart rate | Up to the end of the surgery | Heart rate (beat/min) will be recorded at five-minute intervals until the end of the surgery |
Countries
Egypt
Outcome results
None listed