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Comparing Two Types of Airway Devices (i-GEL and i-GEL plus) in Adult Patients Undergoing Laparoscopic Surgery

Comparison of clinical performance of i-GEL versus i-GEL plus in adult patients going for laparoscopic cholecystectomy under general Anaesthesia: A prospective randomized control study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/092093
Enrollment
126
Registered
2025-07-31
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: K802- Calculus of gallbladder without cholecystitis Health Condition 2: 2- Placement

Interventions

Intervention1: i-gel group: use of i-gel as supraglottic airway (SGA) device for laparoscopic cholecystectomy. monitoring from the time of placement of SGA to 48hours after removal. Control Interventi

Sponsors

Department of Anaesthesiology and Critical Care
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The study included patients of either sex, aged 18-60 years, with a weight range of 30-90 kg, and classified as ASA (American Society of Anesthesiologists) Physical Status I or II. These patients were scheduled to undergo elective laparoscopic cholecystectomy and provided written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: Patients with a body mass index (BMI) of 30 kg/m or higher, or those with any contraindication to supraglottic airway devices, were excluded from the study. Additionally, individuals with certain medical conditions, including cardiac diseases, lung disorders, obesity, and pregnancy, were also excluded. Patients undergoing emergency surgery, as well as those with a history of stroke, or taking medications for neuro-psychiatric disorders, were not eligible. Furthermore, patients with anticipated difficult airways were also excluded from participation.

Design outcomes

Primary

MeasureTime frame
airway morbidity like sore throat, oropharyngeal leak pressure, ease of insertion, patient satisfaction , gastric antral cross section areaTimepoint: 1 minute before and 5 minutes after supraglottic airway device insertion and 2 hours after removal of SGA

Secondary

MeasureTime frame
airway morbidity like sore throatTimepoint: 48 hours after removal of SGA

Countries

India

Contacts

Public ContactTanvi Shukla

King Georges Medical University

aksiddiqui@kgmcindia.edu7052228963

Outcome results

None listed

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