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Comparing two devices which help the patient breathe under general anaesthesia - the endotracheal tube and the supreme laryngeal mask airway, for patients undergoing gall bladder removal surgery laparoscopically.

The comparison between supreme laryngeal mask airway and endotracheal tube with respect to adequacy of ventilation in patients undergoing laparoscopic cholecystectomy under general anaesthesia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/11/010452
Enrollment
132
Registered
2017-11-10
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: null- Patients with gall stones, for removal of the gall bladder, by laparoscopic surgery.

Interventions

Intervention1: Supreme Laryngeal Mask Airway: This is a second generation Supraglottic Airway device, for maintaining airway during general anaesthesia. Control Intervention1: Endotracheal Tube: Consi

Sponsors

PD Hinduja National Hospital and Medical Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Consecutive 132 American Society of Anesthesiologists (ASA) status I and II adults of either sex, aged 20-65 years and body weight 40-80 kg, scheduled for elective laparoscopic cholecystectomy, under general anaesthesia, who had given consent to participate was recruited.

Exclusion criteria

Exclusion criteria: Patients with anticipated difficult airway, Obesity (body mass index >30 kg/m2), Oropharyngeal pathology, Cardiopulmonary disease, Cervical spine fracture or instability, Increased risk of aspiration

Design outcomes

Primary

MeasureTime frame
Adequacy of ventilation i) Quality of glottic airway seal ââ?¬â?? Difference between Inspired tidal volume and Expired tidal volume ii) Oxygen saturation iii) EtCO2 iv) Peak airway pressuresTimepoint: From insertion of airway device to end of anaesthesia.

Secondary

MeasureTime frame
2. Ease of Insertion Time required for achieving effective airway and the number of attempts for securing airway. 3. Haemodynamic responses (heart rate, systolic, diastolic and mean arterial blood pressure) was recorded before induction; at the time of insertion; 1 and 5 min after insertion of device, on pneumoperitoneum inflation and deflation, and on extubation. 4. Complications Incidences of gastric distension, aspiration and post-operative sore throat.Timepoint: From induction of anaesthesia to 24 hours after surgery.

Countries

India

Contacts

Public ContactDeepak Bhushan

P.D. Hinduja National Hospital and Medical Research Centre

nansun2006@gmail.com9820021613

Outcome results

None listed

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