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Clinical Trials/CTRI/2025/09/094230
CTRI/2025/09/094230
Not yet recruiting
Not Applicable

A comparison of I-Gel versus laryngeal mask airway(LMA) supreme for elective short surgical procedures under general anaesthesia with spontaneous ventilation in paediatric patients.

Adesh Institute of Medical Sciences and Research Bathinda1 site in 1 country50 target enrollmentStarted: September 15, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Adesh Institute of Medical Sciences and Research Bathinda
Enrollment
50
Locations
1
Primary Endpoint
To compare the efficacy and safety of I-GEL versus LMA SUPREME for elective short surgical proceduresunder general anaesthesia with spontaneous ventilation in paediatric patients in terms of insertion time ,ease of insertion andnumber of attempts

Overview

Brief Summary

Airway management is fundamental component of successful anaesthesia practice. endotracheal intubation is th gold standard for securing airwy in anaesthetized patient . Inroduction of supraglottic airway devices (SGAs) represented a signifant advancement in airway management  developed by Dr Archie Brain in 1988. It eliminated the requirement of laryngoscopy and reduced the dependance on muscle relaxants.

In paediatric patients , supraglottic airway (SGA) devices are commonly used for a variety of short and minimally invasive surgeries. They have easier and faster placement , less airway trauma, reduced hemodynamic response, and smoother recovery . while they offer disadvantages like they do not protect the airway as effectively as endotracheal tubes  .

I-GEL has non inflatable cuff that provides a reliable seal , reducing the risl of airway trauma compared to traditional endotracheal intubation

LMA SUPREME has inflatable cuff fo a tiht seal at larynx , reducing the risk of air leakage .

the I-GEL  and LMA SUPREME are widely used , but mostly in adults with  limited reserch comparing their effectiveness in paediatric patients who represent unique anatomical and physiological challenges . this study aims to bridge the gap in paediatric SGA research by comparing both devices in terms of ease of insertion , time required for insertion , airway stability and perioperative complications.

these findings will provide valueable insights for optimizing airway management strategies in paediatric patients undergoing short elective surgeries.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
6.00 Month(s) to 6.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All genders ASA Grading I,II Patient undergoing elective short surgeries for duration for 60-90 minutes under general anaesthesia.

Exclusion Criteria

  • Non consenting parents Difficult airway ( MPC CLASS 3 or more) Presence of any disease or surgery of neck,upper respiratory tract and upper gastrointestinal tract Congenital airway abnormalities.

Outcomes

Primary Outcomes

To compare the efficacy and safety of I-GEL versus LMA SUPREME for elective short surgical proceduresunder general anaesthesia with spontaneous ventilation in paediatric patients in terms of insertion time ,ease of insertion andnumber of attempts

Time Frame: To compare the efficacy and safety of I-GEL versus LMA SUPREME for elective short surgical proceduresunder general anaesthesia with spontaneous ventilation in paediatric patients in terms of insertion time ,ease of insertion ,number of attempts and hemodynamics at different time intervals like baseline , at induction , after induction ,every 5 minutes after insertion of Supragottic airway device till 15 minutes .

Secondary Outcomes

  • To compare ease of insertion of gastric catheter.(An appropriate sized lubricated suction catheter will be passed through the gastric channel of device to prevent gastric insulation and ease of insertion will be recorded)
  • To assess hemodynamic parameters.(Variation between the heart rate ,blood pressure respiratory rate ,spo2,and ETCO2 will be recorded before induction , after induction just after SGA insertion then after 5,10,15 minutes after insertion of device .)
  • To compare perioperative complications.(Any complications during insertion of SGA like coughing, gagging ,regurgitation ,vomiting ,patients movement and trauma will be noted.)

Investigators

Sponsor
Adesh Institute of Medical Sciences and Research Bathinda
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Armaandeep Singh

Adesh Institute of Medical Sciences and Research

Study Sites (1)

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