Comparison of different methods of securing airway in patients undergoing surgery under general anaesthesia

Comparison of airway management with I-gel,Cuffed Laryngeal Mask Airway and Cuffed Endotracheal Tube in patients undergoing surgery under general anaesthesia-A Randomized Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063575

Enrollment

150

Registered

2024-03-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Airway will be secured by I-gel: Study participants will be randomized into three groups,each group containing 50 patients.Airway will be secured by I-gel in Group A.At baseline,Inserti

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients aged between 18 to 60years 2.American Society of Anaesthesiologists status I and II 3.Patients undergoing elective surgical procedure under general anaesthesia of duration 60 to 90 minutes 4.Modified Mallampati Score I and II 5.Thyromental distance above 6.5 centimetre

Exclusion criteria

Exclusion criteria: 1.Patients with recognised or threatened risk of gastroesophageal reflux 2.Obese patients with BMI more than 30 3.Pregnant women 4.Patients with co existing cardiac disease 5.Patients on antihypertensives 6.Patients undergoing procedures requiring head and neck manipulation 7.Chronic infection or diseases 8.Patients with history of motion sickness

Design outcomes

Primary

Measure	Time frame
Compare I-gel,Cuffed Laryngeal Mask Airway and cuffed Endotracheal intubation with regards to the ease of insertion,insertion time and number of attemptsTimepoint: Outcome will be assessed after insertion of airway device at baseline.	—

Secondary

Measure	Time frame
To compare the hemodynamic changes after insertion of the airway device & associated side effects if any.Timepoint: Hemodynamic changes will be assessed after insertion of airway device at baseline,every 1 minute until 5 minutes,every 5 minutes until 30 minutes,every 10minutes until the end of surgery.Side effects like blood on removal of device,hoarseness,dysphagia & sore throat will be noted immediately after removing the airway device & 24 hours after surgery.	—

Measure

Time frame

To compare the hemodynamic changes after insertion of the airway device & associated side effects if any.Timepoint: Hemodynamic changes will be assessed after insertion of airway device at baseline,every 1 minute until 5 minutes,every 5 minutes until 30 minutes,every 10minutes until the end of surgery.Side effects like blood on removal of device,hoarseness,dysphagia & sore throat will be noted immediately after removing the airway device & 24 hours after surgery.

—

Countries

India

Contacts

Public ContactDr N Anita Devi

Regional Institute of Medical Sciences,Imphal

dranitadevin@gmail.com8787458045

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026