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Comparing two devices i-gel Plus and i-gel in terms of their performance in patients undergoing laparoscopic cholecystectomy surgery.

Comparative Evaluation Of Oropharyngeal Seal Pressure Of I-gel With I-gel Plus In Adult Patients Undergoing Laparoscopic Cholecystectomy Under General Anaesthesia: A Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092464
Enrollment
72
Registered
2025-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: K80- Cholelithiasis

Interventions

Intervention1: i-gel Plus group: In this group, patient will be put i-gel Plus ,oropharyngeal seal pressures will be measured five minutes after device insertion and five minutes after creating pneumo

Sponsors

Maulana Azad medical college and associated Lok Nayak Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA Grade 1,2,3

Exclusion criteria

Exclusion criteria: 1.Body Mass Index (BMI)Greater Than or equal to 35kg/m2 2.Pregnancy 3.Increased risk of aspiration (such as Gastroesophageal reflux disease, diabetes mellitus etc.) 4. Anticipated difficult airway

Design outcomes

Primary

MeasureTime frame
To compare the mean oropharyngeal seal pressures between i-gel and i-gel Plus five minutes after device insertion under general anaesthesiaTimepoint: It will be done after induction of general anesthesia- five minutes after device insertion.

Secondary

MeasureTime frame
Mean oropharyngeal seal pressure five minutes after creating pneumoperitoneumTimepoint: It will be done intraoperatively five minutes after creating pneumoperitoneum;Time taken for successful device placement.Timepoint: It will be measured in seconds while inserting the device;Number of attempts for successful device placementTimepoint: It will be done after induction of general anaesthesia;Insertion ease of deviceTimepoint: It will be subjective assessment done after induction of general anaesthesia;First attempt success of gastric tube insertionTimepoint: It will be done after device insertion;Brimacombe scoring for assessment of device placementTimepoint: It will be done after device insertion;Complications if any with either deviceTimepoint: It will be done during removal of the device

Countries

India

Contacts

Public ContactSandhiya B

Maulana Azad Medical College

soniawadhawan@hotmail.com9818314062

Outcome results

None listed

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