Comparison of two supraglottic airway devices that are placed over pharynx (i-gel versus ambu auragain) in adult patient undergoing various surgeries under general anesthesia.

Comparison of the clinical performance of the two second generation supraglottic airway devices (I-GEL VS AMBUAURAGAIN) in adult patients undergoing elective surgery. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072520

Enrollment

Registered

2024-08-14

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: 1- Obstetrics Health Condition 3: 8- Other Procedures

Interventions

Intervention1: I-gel: Second generation supraglottic airway device. I-gel is a single use non-inflatable second generation supraglottic airway device designed to avoid compression trauma and has separ

Eligibility

Inclusion criteria

Inclusion criteria: Elective surgeries ASA grade 1 and 2

Exclusion criteria

Exclusion criteria: Mouth opening less then 2.5 cm Full stomach Hiatus hernia Gatsro esophageal reflux disease cervical spine disease pharyngeal pathology laryngeal pathology

Design outcomes

Primary

Measure	Time frame
QUALITY OF INSERTION WORKING PERFORMANCETimepoint: 1) Easy or difficult insertion 2) Number of attempts required for insertion 3) Time taken for insertion 4) Oropharyngeal leak pressure after 10 minutes ofinsertion 5) Airway sealing quality score after 5 minutes of insertion	—

Secondary

Measure	Time frame
PERIOPERATIVE HEMODYNAMIC PARAMETERS (PULSE RATE, SYSTOLIC BP, DIASTOLIC BP, MEAN BP, SPO2, ETCO2)Timepoint: At Baseline, Before induction, Immediately after insertion, At 1 minute after insertion, At 5 min after insertion, At 10 minutes after insertion, At 15 minutes after insertion.;POST OPERATIVE COMPLICATIONSTimepoint: Blood stained device, Tongue-lip-dental trauma, Sore throat, Hoarseness of voice, Bronchospasm or laryngospasm	—

Measure

Time frame

PERIOPERATIVE HEMODYNAMIC PARAMETERS (PULSE RATE, SYSTOLIC BP, DIASTOLIC BP, MEAN BP, SPO2, ETCO2)Timepoint: At Baseline, Before induction, Immediately after insertion, At 1 minute after insertion, At 5 min after insertion, At 10 minutes after insertion, At 15 minutes after insertion.;POST OPERATIVE COMPLICATIONSTimepoint: Blood stained device, Tongue-lip-dental trauma, Sore throat, Hoarseness of voice, Bronchospasm or laryngospasm

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Countries

India

Contacts

Public ContactDr Gauri M Panjabi

Smt NHL Municipal Medical College

gauripanjabi@yahoo.co.in9377244003

Outcome results

None listed

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