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Comparing Two Airway Devices for Safer Anesthesia in Keyhole Gallbladder Surgery.

Comparison of clinical performance of LMA BlockBuster and Ambu AuraGain Supraglottic Airways in Laparoscopic Cholecystectomy: A Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086221
Enrollment
82
Registered
2025-05-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Interventions

Intervention1: Ambu AuraGain (Group A): Ambu AuraGain Supraglottic airway insertion after anaesthesia induction Control Intervention1: Blockbuster (Group B): Blockbuster Supra Glottic Airway (SGA) ins

Sponsors

AIIMS Guwahati
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA physical status I-II 2. Scheduled for elective laparoscopic cholecystectomy

Exclusion criteria

Exclusion criteria: 1. BMI more than 35 kg/m 2. Severe gastroesophageal reflux disease 3. Pregnancy 4. History of upper respiratory tract pathology/surgeries

Design outcomes

Primary

MeasureTime frame
Oropharyngeal leak pressure.Timepoint: N1-0,5,15 MIN N2-0,5,15,30,45,60,75,90 MIN

Secondary

MeasureTime frame
Insertion success rate on the first attemptTimepoint: At SGA insertion time;Insertion timeTimepoint: at SGA insertion;Device insertion attemptsTimepoint: at SGA Insertion;Fiberoptic grade of laryngeal alignmentTimepoint: at SGA Insertion time;Hemodynamic changes: HR and MAPTimepoint: at baseline , immediately after SGA insertion;Ventilation parameters (Peak airway pressure, leak fraction)Timepoint: at 1 min After SGA insertion (T1),5 min Before Carboperitoneum (T2),5 min After Carboperitoneum (T3),5 min Before Removal of Carboperitoneum (T4),5 min After Removal of Carboperitoneum (T5);Incidence of postoperative complications 1. Post-operative sore throat (POST) 2. Hoarseness, 3.Cough 4.Laryngospasm, 5.Blood in SGA on removal Timepoint: first 24 of post operative period

Countries

India

Contacts

Public ContactAspari Mahammad Azeez

All India Institute of Medical Sciences,Guwahati

aspariazeez@gmail.com8427693477

Outcome results

None listed

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