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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spontaneous Ventilation | Active Comparator | Patients will spontaneously ventilated. Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane. |
|
| Unparalyzed Controlled Ventilation | Active Comparator | Patients will be mechanically ventilated without muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane. |
|
| Paralyzed Controlled Ventilation | Active Comparator | Patients will be mechanically ventilated with muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pressure Support Ventilation | Procedure | Ventilator will be adjusted to administer pressure at 10 cmH2O. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of eye movements | Incidence any upward or downward deviation of the vision axis during surgery will be recorded | Up to the end of the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in intraocular pressure | Intraocular pressure will be measured (mmHg) in the non-operative eye using Schioetz-Tonometer | Up to the end of the surgery |
| Changes in bispectral index | Bispectral index values (0-100) will be recorded every five minutes until the end of the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sameh M El-Sherbiny, MD | Mansoura Faculty of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia, Mansoura University Hospitals | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31000891 | Background | 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. | |
| 29027777 |
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| 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. |
|
|
| 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. |
|
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| 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. |
|
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| Sevoflurane | Drug | Sevoflurane in air/oxygen mixture of 40% will be titrated to achieve adequate depth of anesthesia to maintain immobilization of the eye. |
|
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| Up to the end of the surgery |
| Amount of consumption of sevoflurane | Sevoflurane consumption in milliliters will be measured and recorded | Up to the end of the surgery |
| Changes in dynamic compliance | Dynamic compliance (ml /cm H2O) will be recorded after stabilization of ventilation and at the end of surgery | Up to the end of the surgery |
| Changes in heart rate | Heart rate (beat/min) will be recorded at five-minute intervals until the end of the surgery | Up to 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 | Up to 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) | After the end of the surgery |
| 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) | Up to 30 minutes after surgery |
| 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. |
| 28298784 | Background | 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. |
| 31557307 | Background | 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. |
| 30995517 | Background | 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. |
| 24249990 | Background | 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. |
| 28203739 | Background | 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. |
| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014691 | Ventilation |
| D011175 | Positive-Pressure Respiration |
| D017214 | Laryngeal Masks |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D004780 | Environment, Controlled |
| D004777 | Environment |
| D004778 | Environment and Public Health |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
| D007442 | Intubation, Intratracheal |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
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