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

Sponsor
Sameh Fathy (Other)
Overall Status
Completed
CT.gov ID
NCT04241653
Collaborator
(none)
150
Enrollment
1
Location
3
Arms
12.7
Actual Duration (Months)
11.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pressure Support Ventilation
  • Procedure: Unparalyzed Pressure Control Ventilation
  • Procedure: Paralyzed Pressure Control Ventilation
  • Device: Laryngeal Mask Airway
  • Drug: Sevoflurane
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Impact of Different Modes of Ventilation With Laryngeal Mask Airway on Pediatric Cataract Surgery
Actual Study Start Date :
Jan 20, 2020
Actual Primary Completion Date :
Jan 10, 2021
Actual Study Completion Date :
Feb 9, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Spontaneous Ventilation

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

Procedure: Pressure Support Ventilation
Ventilator will be adjusted to administer pressure at 10 cmH2O.
Other Names:
  • Assisted Ventilation

    • Device: Laryngeal 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.
    Other Names:
  • Supraglottic Airway Device

    • Drug: Sevoflurane
    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

    		•
    Active Comparator: Unparalyzed Controlled Ventilation

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

    Procedure: Unparalyzed 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.
    Other Names:
  • Positive pressure Ventilation

    • Device: Laryngeal 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.
    Other Names:
  • Supraglottic Airway Device

    • Drug: Sevoflurane
    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

    		•
    Active Comparator: Paralyzed Controlled Ventilation

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

    Procedure: Paralyzed 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.
    Other Names:
  • Positive pressure Ventilation

    • Device: Laryngeal 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.
    Other Names:
  • Supraglottic Airway Device

    • Drug: Sevoflurane
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    2. 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

    3. Amount of consumption of sevoflurane [Up to the end of the surgery]

      Sevoflurane consumption in milliliters will be measured and recorded

    4. 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

    5. 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

    6. 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

    7. 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)

    8. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 5 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesia, Mansoura University Hospitals Mansoura Dakahlia Egypt 35511

    Sponsors and Collaborators

    • Sameh Fathy

    Investigators

    • Study Director: Sameh M El-Sherbiny, MD, Mansoura Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sameh Fathy, Lecturer of anesthesia, ICU & pain management; Faculty of Medicine, Mansoura University
    ClinicalTrials.gov Identifier:
    NCT04241653
    Other Study ID Numbers:
    • Ventilation with LMA
    First Posted:
    Jan 27, 2020
    Last Update Posted:
    Jun 10, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cataract
    Sevoflurane

    Study Results

    No Results Posted as of Jun 10, 2021