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

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ClinicalTrials.gov Identifier: NCT04241653
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
S Fathy, Mansoura University

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
Ventilation Laryngeal Mask Airway Cataract Surgery Procedure: Pressure Support Ventilation Procedure: Unparalyzed Pressure Control Ventilation Procedure: Paralyzed Pressure Control Ventilation Device: Laryngeal Mask Airway Drug: Sevoflurane Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 20, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Inhalational Anesthesia




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241653


Contacts
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Contact: Sameh M El-Sherbiny, MD +201006500748 Smfsherbiny@yahoo.com
Contact: Amany H El-Deeb, MSc +201008479726 Amanyeldeeb91@hotmail.com

Locations
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Egypt
Department of Anesthesia, Mansoura University Hospitals Recruiting
Mansoura, Dakahlia, Egypt, 35511
Contact: Sameh M El-Sherbiny, MD    +201006500748    Smfsherbiny@yahoo.com   
Sub-Investigator: Sameh M El-Sherbiny, MD         
Principal Investigator: Amany H El-Deeb, MSc         
Sponsors and Collaborators
S Fathy
Investigators
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Study Director: Sameh M El-Sherbiny, MD Mansoura Faculty of Medicine
Publications:

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Responsible Party: S 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: January 27, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Sevoflurane
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General