A research to compare two medical devices used for securing the airway of the patients under general anaesthesia in laparoscopic surgeries of the gall bladder stones.

Phase 4

Not yet recruiting

• Conditions: Calculus of gallbladder without cholecystitis,

• Registration Number: CTRI/2019/04/018497
• Lead Sponsor: GMCH

Brief Summary

This study is a prospective, randomised, parallel group, active controlled trial where two devices, Blockbuster supraglottic airway device and Endotracheal tube, will be used for securing the patency of the airway during general anaesthesia and will be compared in terms of ventilatory parameters and airway dynamics in laparoscopic cholecystectomy surgeries. Secondary outcome will measure hemodynamic parameters between the two devices.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-21
• Last Update Posted: 2019-05-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA 1 or 2.
• Patients scheduled for elective laparoscopic cholecystectomy surgery under general anaesthesia.

Exclusion Criteria

• Patients with anticipted difficult airway.
• Patients with upper respiratory tract infection.
• Patients with increased risk of regurgitation and aspiration of gastric contents.
• Patients with a body mass index > 35kg/m2.
• Pregnant patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ventilatory parameters (peak airway pressure, plateau pressure, mean airway pressure, inspiratory and expiratory tidal volume, inspiratory and expiratory minute ventilation, inspiratory expiratory ratio, compliance, airway resistance,end tidal carbon dioxide)	After intubation/Supraglottic airway device placement, before carboperitoneum, after carboperitoneum, at 10 minutes after position, after release of carboperitoneum.

Secondary Outcome Measures

Name	Time	Method
Hemodynamic parameters (non invasive blood pressure[systolic, diastolic, mean arterial pressure], heart rate, oxygen saturation.	Baseline, after induction, after intubation/Supraglottic airway device placement, before carboperitoneum, after carboperitoneum, at 10 minutes after position, after release of carboperitoneum, after extubation/Supraglottic airway device removal

Trial Locations

Locations (1)

Government medical college and hospital, sector 32, Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

Government medical college and hospital, sector 32, Chandigarh

🇮🇳Chandigarh, CHANDIGARH, India

Arshdeep Kaur

Principal investigator

8360081819

randhawa.arsh1406@gmail.com