A Comparative Evaluation Between Baska Mask AND I-gel For Oropharyngeal Leak Pressure In Patients Undergoing Surgery Under General Anesthesia- A Prospective Randomized Controlled Study.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Oropharyngeal Leak Pressure
Study Overview
Brief Summary
A Comparative Evaluation Between Baska Mask And I-gel For Oropharyngeal Leak Pressure In Patients Undergoing Surgery Under General Anaesthesia- A Prospective Randomized Controlled Study.
Having a proper airway is the most important factor in establishing normal respiration during surgery under general anaesthesia. Supraglottic Airway Devices(SAD) are claimed to produce no cardiopulmonary response during intubation, nor stimulate laryngeal reflexes, require fewer anaesthetic medications, and to have fewer complications and side effects such as coughing during awakening or sore throat.
Baska mask Isa new supraglottic noninflatable airway device that has a self sealing membranous cuff that inflates during inspiration and deflates during expiration. An inbuilt tab facilitates insertion of the device. It also has an oesophageal drainage inlet, a side channel to facilitate aspiration of gastric contents and an integral bite-block.
The I-gel is a supraglottic airway device with an anatomically designed non-inflatable mask that snugly fits onto the peri-laryngeal framework. The device has a buccal cavity stabiliser with an airway channel and a gastric tube insertion channel.
In our study, we aim to compare the efficacy of Baska mask with I-gel in terms of Oropharyngeal leak pressure, Intubation time, number of attempts for successful intubation, POGO score, ease of insertion of device, changes in Hear Rate, Blood Pressure following insertion and removal of device in patients undergoing surgery under general anaesthesia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Written and informed consent
- •Weight between 40-80 kg
- •ASA Grade 1 and 2 patients
- •All MP Grades
- •Patents planned for elective surgery requiring general anaesthesia.
Exclusion Criteria
- •1.Any pathology of oral cavity that may obstruct the insertion of device or mouth openings less than 2.5 cm Expected duration of surgery longer than 2 hours
- •Potential full stomach patients (trauma, morbid obesity, pregnancy, history of gastric regurgitation and heart burn) and at risk of esophageal reflux (hiatus hernia)
- •Lack of consent to participate in the study.
Outcomes
Primary Outcomes
Oropharyngeal Leak Pressure
Time Frame: Leak Pressure will be noted immediately following mask insertion and 10 min of surgery at which equilibrium will be reached
Secondary Outcomes
- 1.Comparison of ease of insertion.(2.Comparison in attempts to insert the device.)
Investigators
Md Parwez Alam
DEPARTMENT OF ANAESTHESIOLOGY Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh