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Completed

NCT Number: NCT04241653

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

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.

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Key information

Conditions

Ventilation Cataract Surgery Laryngeal Mask Airway Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pressure support ventilation

Procedure

Ventilator will be adjusted to administer pressure at 10 cmH2O.

Other names: Assisted Ventilation

Unparalyzed Pressure Control Ventilation

Procedure

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.

Other names: Positive pressure Ventilation

Paralyzed Pressure Control Ventilation

Procedure

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.

Other names: Positive pressure Ventilation

Laryngeal mask airway

Device

Capnography connected to laryngeal mask airway is introduced after adequate jaw relaxation; its size is chosen according to the body weight of the child.

Other names: Supraglottic Airway Device

Sevoflurane

Drug

Sevoflurane in air/oxygen mixture of 40% will be titrated to achieve adequate depth of anesthesia to maintain immobilization of the eye.

Other names: Inhalational Anesthesia

Primary outcomes

  1. Incidence of eye movements

    Time frame: Up to the end of the surgery

    Incidence any upward or downward deviation of the vision axis during surgery will be recorded

Secondary outcomes

  1. Changes in intraocular pressure

    Time frame: Up to the end of the surgery

    Intraocular pressure will be measured (mmHg) in the non-operative eye using Schioetz-Tonometer

  2. Changes in bispectral index

    Time frame: Up to the end of the surgery

    Bispectral index values (0-100) will be recorded every five minutes until the end of the surgery

  3. Amount of consumption of sevoflurane

    Time frame: Up to the end of the surgery

    Sevoflurane consumption in milliliters will be measured and recorded

  4. Changes in dynamic compliance

    Time frame: 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

  5. Changes in heart rate

    Time frame: Up to the end of the surgery

    Heart rate (beat/min) will be recorded at five-minute intervals until the end of the surgery

  6. Changes in mean arterial blood pressure

    Time frame: Up to the end of the surgery

    Blood pressure (mmHg) will be recorded at five-minute intervals until the end of the surgery

  7. Value of surgeon satisfaction from the procedure

    Time frame: 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)

  8. Improvement in postoperative emergence agitation scale

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Sameh Fathy

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2020
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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