CTRI/2024/10/075734
Not yet recruiting
Not Applicable
Comparison of Proseal Laryngeal Mask Airway with i-Gel in Elective Urological Surgeries - A Randomized clinical trial
ADHILAKSHMI R1 site in 1 country116 target enrollmentStarted: November 1, 2024Last updated:
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- ADHILAKSHMI R
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Hemodynamic Changes
Overview
Brief Summary
This study proposal outlines a randomized controlled trial (RCT) aimed at comparing the Proseal Laryngeal Mask Airway (Proseal LMA) with the i-Gel in adult patients undergoing elective urological surgery. The primary objective is to assess and compare the efficacy, safety, and feasibility of these two airway management devices in terms of insertion success, airway sealing, and hemodynamic complications. The study will contribute to the evidence base, guiding anesthesiologists in choosing the most suitable airway device for elective surgical procedures.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult patients aged 18-65 years.
- •Scheduled for elective urological (less than 4 hours) surgery under general anesthesia.
- •American Society of Anesthesiologists (ASA) physical status I or II.
Exclusion Criteria
- •Patients requiring
- •Endotracheal intubation Emergency surgeries.
- •Known or anticipated difficult airway.
- •Prolonged surgical procedures for more than 4 hours
- •At risk of aspiration (pregnancy and gastro esophageal reflex disease).
Outcomes
Primary Outcomes
Hemodynamic Changes
Time Frame: At baseline, | At 1st Minute, | At 5th Minute
Secondary Outcomes
- Airway seal pressure (cmH2O).(Hemodynamic stability (heart rate, respiratory rate, spo2 and blood pressure).)
Investigators
Dr Meera Rani Nayak
Dr. Kamakshi Memorial Hospital
Study Sites (1)
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