Two ventilatory device are being compared in this study for ventilation in laparoscopic surgery done for removal of gall bladder.
- Conditions
- Calculus of gallbladder with acutecholecystitis,
- Registration Number
- CTRI/2023/09/057309
- Lead Sponsor
- Vardhman Mahavir Medical College and Safdarjung hospital
- Brief Summary
The study is a prospective ranadmoized interventional comparative study to compare clinical efficacy of Laryngeal Mask Airway Protector with Laryngeal mask airway Proseal for ventilation, in patients undergoing laparoscopic cholecystectomy under general anaesthesia, with hypothesis that the clinical efficacy of laryngeal mask airway Protector is equivalent to that of laryngeal mask airway ProSeal for ventilation in terms of oropharyngeal leak pressure in patients undergoing laparoscopic cholecystectomy under general anaesthesia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 144
144 patients, in age group of 18 to 60 years, American society of Anaesthesiologists (ASA) physical status I and II undergoing laparoscopic cholecystectomy under general anaesthesia.
Patients with anticipated difficult airway including: Thyromental distance<6.5 cm, Upper lip bite test class<1, Mallampati class III and IV, Restricted head and neck mobility, Mouth opening <3.5 cm, BMI>30kg/m2, Cervical spine pathology, High risk of aspiration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Oropharyngeal leak pressure will be noted within 5 minutes after device insertion. Oropharyngeal leak pressure will be noted within 5 minutes after device insertion. | Other reading of oropharyngeal leak pressure will be taken after inflation & after deflation of carboperitoneum. Other reading of oropharyngeal leak pressure will be taken after inflation & after deflation of carboperitoneum. Oropharyngeal leak pressure will be noted within 5 minutes after device insertion. | Other reading of oropharyngeal leak pressure will be taken after inflation & after deflation of carboperitoneum.
- Secondary Outcome Measures
Name Time Method insertion characteristics 1.NUMBER OF ATTEMPTS TAKEN FOR SUCCESSFUL INSERTION OF DEVICE
Trial Locations
- Locations (1)
Vardhman Mahavir Medical College and Safdarjung hospital
🇮🇳Delhi, DELHI, India
Vardhman Mahavir Medical College and Safdarjung hospital🇮🇳Delhi, DELHI, IndiaNidhi KharbPrincipal investigator9811472730nidhikharb4@gmail.com