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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2021-02-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

New Technique in Congenital/Pediatric Cataract Surgery

NCT05278936

Pediatric Cataract Congenital Cataract

COMPLETED NA

Evaluation of Intraoperative Lagophthalmos Formula

NCT04291625

Ptosis, Eyelid

COMPLETED NA

Combined Phacoaspiration and Angle Surgery Versus Phacoaspiration in Pediatric Cataract

NCT05401760

Pediatric Glaucoma

UNKNOWN NA

Combined Intracameral Lidocaine for Manual Small Incision Cataract Surgery Under Topical Anesthesia

NCT01023334

Cataract

COMPLETED NA

Venturi and Peristaltic Based Phacoemulsification in Femtosecond Laser Cataract Surgery

NCT03970525

Cataract Senile

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventilation Laryngeal Mask Airway Cataract Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Spontaneous Ventilation

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

Group Type ACTIVE_COMPARATOR

Pressure Support Ventilation

Intervention Type PROCEDURE

Ventilator will be adjusted to administer pressure at 10 cmH2O.

Laryngeal Mask Airway

Intervention Type 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.

Sevoflurane

Intervention Type DRUG

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

Unparalyzed Controlled Ventilation

Patients will be mechanically ventilated without muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.

Group Type ACTIVE_COMPARATOR

Unparalyzed Pressure Control Ventilation

Intervention Type 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.

Laryngeal Mask Airway

Intervention Type 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.

Sevoflurane

Intervention Type DRUG

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

Paralyzed Controlled Ventilation

Patients will be mechanically ventilated with muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.

Group Type ACTIVE_COMPARATOR

Paralyzed Pressure Control Ventilation

Intervention Type 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.

Laryngeal Mask Airway

Intervention Type 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.

Sevoflurane

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pressure Support Ventilation

Ventilator will be adjusted to administer pressure at 10 cmH2O.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Sevoflurane

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Assisted Ventilation Positive pressure Ventilation Positive pressure Ventilation Supraglottic Airway Device Inhalational Anesthesia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No