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Comparison of two breathing devices, Baska Mask and i-gel, used during gallbladder keyhole surgery under general anaesthesia to improve safety

Comparative evaluation of Baska Mask and I-gel in patients undergoing laparoscopic cholecystectomy under general anaesthesia: A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097997
Enrollment
136
Registered
2025-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: K801- Calculus of gallbladder with othercholecystitis

Interventions

Intervention1: Baska mask: Securing the airway with Baska mask and comparing clinical efficiency with I Gel during surgery and complications upto 24 hours after surgery Control Intervention1: I Gel: S

Sponsors

Swami Dayanand Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 to 60 years of either sex. ASA Grade 1& II. Patients undergoing laparoscopic cholecystectomy under general anaesthesia.

Exclusion criteria

Exclusion criteria: Patients with inadequate mouth opening to permit insertion. Known difficult airway. Pathology of neck, upper respiratory tract or upper gastrointestinal tract. History of obstructive sleep apnea History of lung disease Patients with high risk of aspiration like pregnant females, known case of gastroesophageal reflux disease, hiatus hernia, Obese patients with BMI greater than or equal to30 kg/m

Design outcomes

Primary

MeasureTime frame
To compare oropharyngeal leak pressures between the two devices at the end of 5th minute of pneumoperitoneum.Timepoint: At the end of 5th minute of pneumoperitoneum.—

Secondary

MeasureTime frame
To compare fibreoptic grading of supraglottic airway device positionTimepoint: After insertion;To compare time taken for insertion and number of attempts for the supraglottic airway device insertion.Timepoint: After insertion;To compare the ease of insertion of gastric tube.Timepoint: After insertion;To compare Hemodynamics Response which include Pulse Rate, Mean arterial pressure (MAP), SpO2 and End Tidal Carbon dioxide.Timepoint: During surgery;To compare post operative complications like blood staining of the supraglottic device tip, visible mucosal damage, sore throat, cough or any other complaintsTimepoint: At the end of surgery and after 24 hours after surgery—

Countries

India

Contacts

Public ContactDr Kottada Udaya Hari Vidya Sagar

Swami Dayanand Hospital

drdangi679@gmail.com9810710458

Outcome results

None listed

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