Comparison of 2 supraglottic airway devices,Ambu AuraGain Vs BlockBuster Laryngeal Mask, in laproscopic surgeries in children

A randomized coparativesuty of AmbuAuraGain Vs BlockBuster Laryngeal Mask for controlled ventilation in paediatric laparoscopic surgeries under general anaesthesia in Department of Anaesthesia, S.M.S Medical College and Attached hospitals, Jaipur. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087184

Enrollment

Registered

2025-05-20

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: 4- Measurement and Monitoring Health Condition 2: K36- Other appendicitis Health Condition 3: K80- Cholelithiasis Health Condition 4: Q53- Undescended and ectopic testicle Health Condition 5: N130- Hydronephrosis with ureteropelvicjunction obstruction

Interventions

Intervention1: Insertion of Ambu AuraGain: After receiving and identifying the patient, using sealed envelope technique, the type of Supraglottic device is selected. After induction, an appr

Ambu AuraGain and BlockBuster: After induction of anaesthesia, the ventilatory parameters and the oropharyngeal leak pressure after insertion of LMA and 10 mins after pneumoperitoneum creation are che

Eligibility

Inclusion criteria

Inclusion criteria: 1 ASA physical statuses 1 and 2 2 Undergoing elective laparoscopic surgeries. 3 Informed written consent from parent/guardian for the study.

Exclusion criteria

Exclusion criteria: 1. Syndromic children with difficult airway, intraoral pathology. 2. Patients who had recent respiratory tract infections. 3. Patients with risk of aspiration. 4. Patient should not be part of any other study. 5) Non cooperative patient

Design outcomes

Primary

Measure	Time frame
1.The difference in Oropharyngeal Leak Pressure between the two supraglottic devices immediately after insertion and 10 minutes after pneumoperitoneum creation. 2.The difference in ventilatory parameters (tidal volume, respiratory rate, leak and peak airway pressure) between the two supraglottic devices.Timepoint: 1. Oropharyngeal leak pressure is checked immediately and 10mins after pneumoperitoneum creation 2. Ventilatory parameters: Immediately after insertion of LMA, after patient positioning, after preumoperitoneum creation, 10mins after preumoperitoneum creation	—

Measure

Time frame

1.The difference in Oropharyngeal Leak Pressure between the two supraglottic devices immediately after insertion and 10 minutes after pneumoperitoneum creation. 2.The difference in ventilatory parameters (tidal volume, respiratory rate, leak and peak airway pressure) between the two supraglottic devices.Timepoint: 1. Oropharyngeal leak pressure is checked immediately and 10mins after pneumoperitoneum creation 2. Ventilatory parameters: Immediately after insertion of LMA, after patient positioning, after preumoperitoneum creation, 10mins after preumoperitoneum creation

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Secondary

Measure	Time frame
1.To determine the differences in insertion characteristics between the two supraglottic devices in terms of time taken for insertion of device, number of attempts taken & ease of insertion. 2.To determine the difference in fiberoptic grading of glottis in both the groups. 3.To determine the difference in gastric tube insertion 4.To determine the difference in percentage of complications (laryngospasm, bronchospasm, blood staining on the back of the device, dysphagia & dysphonia) in both the groups.Timepoint: I. Differences in insertion characteristics, fibreoptic grading of glottis, gastric tube insertion are checked immediately after LMA insertion 2. Postoperative complications are checked after the surgery. Dysphagia checked 24 hours after surgery	—

Measure

Time frame

1.To determine the differences in insertion characteristics between the two supraglottic devices in terms of time taken for insertion of device, number of attempts taken & ease of insertion. 2.To determine the difference in fiberoptic grading of glottis in both the groups. 3.To determine the difference in gastric tube insertion 4.To determine the difference in percentage of complications (laryngospasm, bronchospasm, blood staining on the back of the device, dysphagia & dysphonia) in both the groups.Timepoint: I. Differences in insertion characteristics, fibreoptic grading of glottis, gastric tube insertion are checked immediately after LMA insertion 2. Postoperative complications are checked after the surgery. Dysphagia checked 24 hours after surgery

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Countries

India

Contacts

Public ContactDr. Neelam Dogra

JK Lone Hospital, Under S.M.S Medical College and Attached Hospitals

neelam_dogra24@yahoo.com9928709289

Outcome results

None listed

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