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Clinical Trials/CTRI/2024/03/063834
CTRI/2024/03/063834
Not yet recruiting
Not Applicable

Comparison of Proseal laryngeal mask airway and Baska mask in adult patients undergoing laparoscopic surgeries under general anaesthesia : Randomised control trial.

Teerthanker Mahaveer Medical College , Moradabad , Uttar pradesh1 site in 1 country90 target enrollmentStarted: March 20, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Teerthanker Mahaveer Medical College , Moradabad , Uttar pradesh
Enrollment
90
Locations
1
Primary Endpoint
Primary outcome to be assessed

Overview

Brief Summary

This study is planned in context that supraglottic third generation device Baska mask is recently introduced in clinical uses and there are limited number of comparative clinical studies available to compare second generation Proseal laryngeal mask airway and Baska mask efficacy , oropharyngeal leak pressure , ease of insertion , hemodynamic profile, anatomical alignment and complication of both devices in adult patients undergoing laparoscopic surgeries under general anaesthesia.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Adult patients of the American Society of Anaesthesiologists physical status I and II , mallampati score 1 and 2 , scheduled to undergo laparoscopic surgeries under general anaesthesia , informed and written consent.

Exclusion Criteria

  • Adult patients with anticipated difficult airway, BMI more than 30kg/m2, high risk of aspiration and pregnancy, operation time more than 4 hours , cervical spine pathology.

Outcomes

Primary Outcomes

Primary outcome to be assessed

Time Frame: 5 minutes,15 minutes, 20 minutes after pneumoperitoneum

1.To compare oropharyngeal leak pressure in both the groups.

Time Frame: 5 minutes,15 minutes, 20 minutes after pneumoperitoneum

2.To compare ease of insertion in both the groups.

Time Frame: 5 minutes,15 minutes, 20 minutes after pneumoperitoneum

Secondary Outcomes

  • Each participant in the study will be assessed for following Secondary outcome parameters are as follows :-(1.To note the number of attempts of insertion in both the groups.)

Investigators

Sponsor
Teerthanker Mahaveer Medical College , Moradabad , Uttar pradesh
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Simran Saroha

Teerthanker Mahaveer Medical College And Research Centre

Study Sites (1)

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