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

NCT04241653 | Completed

• 1 other identifier: Ventilation with LMA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilation; Laryngeal Mask Airway; Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Changes in intraocular pressure

  Up to the end of the surgery

• Changes in bispectral index

  Up to the end of the surgery

• Amount of consumption of sevoflurane

  Up to the end of the surgery

• Changes in dynamic compliance

  Up to the end of the surgery

• Changes in heart rate

  Up to the end of the surgery

Study Arms (3)

Spontaneous Ventilation

ACTIVE COMPARATOR

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

Procedure: Pressure Support Ventilation; Device: Laryngeal Mask Airway; Drug: 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.

Procedure: Unparalyzed Pressure Control Ventilation; Device: Laryngeal Mask Airway; Drug: 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.

Procedure: Paralyzed Pressure Control Ventilation; Device: Laryngeal Mask Airway; Drug: Sevoflurane

Interventions

Pressure Support Ventilation PROCEDURE

Ventilator will be adjusted to administer pressure at 10 cmH2O.

Also known as: Assisted Ventilation

Spontaneous Ventilation

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.

Also known as: Positive pressure Ventilation

Unparalyzed Controlled Ventilation

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.

Also known as: Positive pressure Ventilation

Paralyzed Controlled Ventilation

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.

Also known as: Supraglottic Airway Device

Paralyzed Controlled Ventilation; Spontaneous Ventilation; Unparalyzed Controlled Ventilation

Sevoflurane DRUG

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

Also known as: Inhalational Anesthesia

Paralyzed Controlled Ventilation; Spontaneous Ventilation; Unparalyzed Controlled Ventilation

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiology (ASA) I and II patients.
• Scheduled for elective cataract surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sameh Fathy: lead

Study Sites (1)

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related 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.

  PMID: 31000891 BACKGROUND

• 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.

  PMID: 29027777 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.

  PMID: 28298784 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.

  PMID: 31557307 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.

  PMID: 30995517 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.

  PMID: 24249990 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.

  PMID: 28203739 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Ventilation; Positive-Pressure Respiration; Laryngeal Masks; Sevoflurane

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Intubation, Intratracheal; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Sameh M El-Sherbiny, MD

  Mansoura Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: January 20, 2020
• Primary Completion: January 10, 2021
• Study Completion: February 9, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)