Impact of Different Modes of Ventilation With Laryngeal Mask Airway on Pediatric Cataract Surgery
Condition: Ventilation; Laryngeal Mask Airway; Cataract Surgery
MeSH terms: Cataract
Study type: Interventional

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.
    

Intervention name(s): Pressure Support Ventilation; Unparalyzed Pressure Control Ventilation; Paralyzed Pressure Control Ventilation; Laryngeal Mask Airway; Sevoflurane
Intervention type(s): Procedure; Procedure; Procedure; Device; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Assisted Ventilation; Positive pressure Ventilation; Positive pressure Ventilation; Supraglottic Airway Device; Inhalational Anesthesia
Intervention MeSH terms: Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment