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

Cataract Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04241653
• Other study ID #: Ventilation with LMA
• Status: Completed
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: February 9, 2021

Study information

• Verified date: June 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 9, 2021
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery
• Laryngeal Mask Airway
• Ventilation

Intervention

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

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.

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

Locations

Country	Name	City	State
Egypt	Department of Anesthesia, Mansoura University Hospitals	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Sameh Fathy

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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. — View Citation

Fudickar A, Gruenewald M, Fudickar B, Hill M, Wallenfang M, Hüllemann 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. — View 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. — View 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:CD003843. doi: 10.1002/14651858.CD003843.pub4. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Changes in bispectral index	Bispectral index values (0-100) will be recorded every five minutes until the end of the surgery	Up to the end of the surgery
Secondary	Amount of consumption of sevoflurane	Sevoflurane consumption in milliliters will be measured and recorded	Up to the end of the surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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