Impact of Different Modes of Ventilation With Laryngeal Mask Airway on Pediatric Cataract Surgery
Primary Purpose
Ventilation, Laryngeal Mask Airway, Cataract Surgery
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pressure Support Ventilation
Unparalyzed Pressure Control Ventilation
Paralyzed Pressure Control Ventilation
Laryngeal Mask Airway
Sevoflurane
Sponsored by
About this trial
This is an interventional treatment trial for Ventilation
Eligibility 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.
Sites / Locations
- Department of Anesthesia, Mansoura University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Spontaneous Ventilation
Unparalyzed Controlled Ventilation
Paralyzed Controlled Ventilation
Arm Description
Patients will spontaneously ventilated. Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Patients will be mechanically ventilated without muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Patients will be mechanically ventilated with muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Outcomes
Primary Outcome Measures
Incidence of eye movements
Incidence any upward or downward deviation of the vision axis during surgery will be recorded
Secondary Outcome Measures
Changes in intraocular pressure
Intraocular pressure will be measured (mmHg) in the non-operative eye using Schioetz-Tonometer
Changes in bispectral index
Bispectral index values (0-100) will be recorded every five minutes until the end of the surgery
Amount of consumption of sevoflurane
Sevoflurane consumption in milliliters will be measured and recorded
Changes in dynamic compliance
Dynamic compliance (ml /cm H2O) will be recorded after stabilization of ventilation and at the end of surgery
Changes in heart rate
Heart rate (beat/min) will be recorded at five-minute intervals until the end of the surgery
Changes in mean arterial blood pressure
Blood pressure (mmHg) will be recorded at five-minute intervals until the end of the surgery
Value of surgeon satisfaction from the procedure
The ophthalmogist will be investigated postoperatively for the quality of surgical field (0-8; 0=None, 8=total satisfaction)
Improvement in postoperative emergence agitation scale
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04241653
Brief Title
Impact of Different Modes of Ventilation With Laryngeal Mask Airway on Pediatric Cataract Surgery
Official Title
Impact of Different Modes of Ventilation With Laryngeal Mask Airway on Pediatric Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
January 10, 2021 (Actual)
Study Completion Date
February 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sameh Fathy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilation, Laryngeal Mask Airway, Cataract Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spontaneous Ventilation
Arm Type
Active Comparator
Arm Description
Patients will spontaneously ventilated. Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Arm Title
Unparalyzed Controlled Ventilation
Arm Type
Active Comparator
Arm Description
Patients will be mechanically ventilated without muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Arm Title
Paralyzed Controlled Ventilation
Arm Type
Active Comparator
Arm Description
Patients will be mechanically ventilated with muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Intervention Type
Procedure
Intervention Name(s)
Pressure Support Ventilation
Other Intervention Name(s)
Assisted Ventilation
Intervention Description
Ventilator will be adjusted to administer pressure at 10 cmH2O.
Intervention Type
Procedure
Intervention Name(s)
Unparalyzed Pressure Control Ventilation
Other Intervention Name(s)
Positive pressure Ventilation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Paralyzed Pressure Control Ventilation
Other Intervention Name(s)
Positive pressure Ventilation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Laryngeal Mask Airway
Other Intervention Name(s)
Supraglottic Airway Device
Intervention Description
Capnography connected to laryngeal mask airway is introduced after adequate jaw relaxation; its size is chosen according to the body weight of the child.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Inhalational Anesthesia
Intervention Description
Sevoflurane in air/oxygen mixture of 40% will be titrated to achieve adequate depth of anesthesia to maintain immobilization of the eye.
Primary Outcome Measure Information:
Title
Incidence of eye movements
Description
Incidence any upward or downward deviation of the vision axis during surgery will be recorded
Time Frame
Up to the end of the surgery
Secondary Outcome Measure Information:
Title
Changes in intraocular pressure
Description
Intraocular pressure will be measured (mmHg) in the non-operative eye using Schioetz-Tonometer
Time Frame
Up to the end of the surgery
Title
Changes in bispectral index
Description
Bispectral index values (0-100) will be recorded every five minutes until the end of the surgery
Time Frame
Up to the end of the surgery
Title
Amount of consumption of sevoflurane
Description
Sevoflurane consumption in milliliters will be measured and recorded
Time Frame
Up to the end of the surgery
Title
Changes in dynamic compliance
Description
Dynamic compliance (ml /cm H2O) will be recorded after stabilization of ventilation and at the end of surgery
Time Frame
Up to the end of the surgery
Title
Changes in heart rate
Description
Heart rate (beat/min) will be recorded at five-minute intervals until the end of the surgery
Time Frame
Up to the end of the surgery
Title
Changes in mean arterial blood pressure
Description
Blood pressure (mmHg) will be recorded at five-minute intervals until the end of the surgery
Time Frame
Up to the end of the surgery
Title
Value of surgeon satisfaction from the procedure
Description
The ophthalmogist will be investigated postoperatively for the quality of surgical field (0-8; 0=None, 8=total satisfaction)
Time Frame
After the end of the surgery
Title
Improvement in postoperative emergence agitation scale
Description
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)
Time Frame
Up to 30 minutes after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh M El-Sherbiny, MD
Organizational Affiliation
Mansoura Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anesthesia, Mansoura University Hospitals
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31000891
Citation
Dias R, Dave N, Agrawal B, Baghele A. Correlation between bispectral index, end-tidal anaesthetic gas concentration and difference in inspired-end-tidal oxygen concentration as measures of anaesthetic depth in paediatric patients posted for short surgical procedures. Indian J Anaesth. 2019 Apr;63(4):277-283. doi: 10.4103/ija.IJA_653_18.
Results Reference
background
PubMed Identifier
29027777
Citation
Fudickar A, Gruenewald M, Fudickar B, Hill M, Wallenfang M, Hullemann J, Voss D, Caliebe A, Roider JB, Steinfath M, Treumer F. Immobilization during anesthesia for vitrectomy using a laryngeal mask without neuromuscular blockade versus endotracheal intubation and neuromuscular blockade. Minerva Anestesiol. 2018 Jul;84(7):820-828. doi: 10.23736/S0375-9393.17.12282-0. Epub 2017 Oct 12.
Results Reference
background
PubMed Identifier
28298784
Citation
Ghabach MB, El Hajj EM, El Dib RD, Rkaiby JM, Matta MS, Helou MR. Ventilation of Nonparalyzed Patients Under Anesthesia with Laryngeal Mask Airway, Comparison of Three Modes of Ventilation: Volume Controlled Ventilation, Pressure Controlled Ventilation, and Pressure Controlled Ventilation-volume Guarantee. Anesth Essays Res. 2017 Jan-Mar;11(1):197-200. doi: 10.4103/0259-1162.200238.
Results Reference
background
PubMed Identifier
31557307
Citation
Lewis SR, Pritchard MW, Fawcett LJ, Punjasawadwong Y. Bispectral index for improving intraoperative awareness and early postoperative recovery in adults. Cochrane Database Syst Rev. 2019 Sep 26;9(9):CD003843. doi: 10.1002/14651858.CD003843.pub4.
Results Reference
background
PubMed Identifier
30995517
Citation
Waldschmidt B, Gordon N. Anesthesia for pediatric ophthalmologic surgery. J AAPOS. 2019 Jun;23(3):127-131. doi: 10.1016/j.jaapos.2018.10.017. Epub 2019 Apr 14.
Results Reference
background
PubMed Identifier
24249990
Citation
Singh PM, Trikha A, Sinha R, Borle A. Measurement of consumption of sevoflurane for short pediatric anesthetic procedures: Comparison between Dion's method and Dragger algorithm. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):516-20. doi: 10.4103/0970-9185.119160.
Results Reference
background
PubMed Identifier
28203739
Citation
Mason KP. Paediatric emergence delirium: a comprehensive review and interpretation of the literature. Br J Anaesth. 2017 Mar 1;118(3):335-343. doi: 10.1093/bja/aew477.
Results Reference
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Impact of Different Modes of Ventilation With Laryngeal Mask Airway on Pediatric Cataract Surgery
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