CTRI/2024/06/068772Not yet recruitingPhase 2/3
A prospective randomised study Comparing clinical performance of AMBU AURAGAIN and LMA BLOCKBUSTER in adult patients undergoing general anaesthesia for elective surgeries.
Department of Anaesthesiology1 site in 1 country90 target enrollmentStarted: June 26, 2024Last updated:
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Oropharyngeal seal pressure(OSP)
Study Overview
Brief Summary
It is a prospective randomised study comparing clinical performance of AMBU AURAGAIN and LMA BLOCKBUSTER in adult patients undergoing general anaesthesia for elective surgeries of less than 2 hrs duration.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA grade I and grade II Patients.
- •Age- 18 to 65 years of either sex.
- •Patients undergoing surgery under general anaesthesia.
- •Anticipated normal airway in preanaesthetic evaluation.
- •Posted for surgery requiring supine position only.
Exclusion Criteria
- •Patients with anticipated difficult airway
- •Anticipated high risk of aspiration (hiatus hernia, full stomach, pregnancy, gastro-oesophageal reflux).
- •Preoperative respiratory tract infection.
- •Patients with history of allergy or sensitivity to any medication, latex or egg.
Outcomes
Primary Outcomes
Oropharyngeal seal pressure(OSP)
Time Frame: Once after insertion of supraglottic airway device
Secondary Outcomes
- Number of attempts taken(For successful insertion of device)
- Time taken for effective insertion(Upto securing the airway)
- Ease of insertion of device and gastric tube placement(During insertion of device)
- Hemodynamic parameters (BP, HR, SPO2)(Baseline, every 5 minutes for initial 15 minutes and then every 15 minutes till end of the surgery.)
- Post-op complications (Displacement, blood staining, Sore throat, hoarseness, injury)(After extubation)
Investigators
Dr Sweta
LLRM Medical College
Study Sites (1)
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