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.

Not Applicable

Completed

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

• Registration Number: CTRI/2017/11/010452
• Lead Sponsor: PD Hinduja National Hospital and Medical Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-06-04
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 132

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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