Impact of Different Modes of Ventilation With Laryngeal Mask Airway on Pediatric Cataract Surgery

Sameh Fathy

Status: Completed

Conditions: Ventilation; Laryngeal Mask Airway; Cataract Surgery

Treatments: Procedure: Unparalyzed Pressure Control Ventilation; Device: Laryngeal Mask Airway; Drug: Sevoflurane; Procedure: Paralyzed Pressure Control Ventilation; Procedure: Pressure Support Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT04241653

Ventilation with LMA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Spontaneous Ventilation

Active Comparator group

Description:

Patients will spontaneously ventilated. Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.

Treatment:

Procedure: Pressure Support Ventilation

Drug: Sevoflurane

Device: Laryngeal Mask Airway

Unparalyzed Controlled Ventilation

Active Comparator group

Description:

Patients will be mechanically ventilated without muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.

Treatment:

Drug: Sevoflurane

Device: Laryngeal Mask Airway

Procedure: Unparalyzed Pressure Control Ventilation

Paralyzed Controlled Ventilation

Active Comparator group

Description:

Patients will be mechanically ventilated with muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.

Treatment:

Drug: Sevoflurane

Procedure: Paralyzed Pressure Control Ventilation

Device: Laryngeal Mask Airway