Laryngeal Mask Airway Supreme vs I gel A Comparison Of First Attempt Success Rate Among Novices
Overview
- Phase
- Post Marketing Surveillance
- Status
- Not yet recruiting
- Sponsor
- SRM Medical College Hospital
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- To compare the first attempt success rate among novices between LMA supreme and I-gel in patients undergoing elective procedures under general anesthesia
Overview
Brief Summary
The study will be conducted post approval from IEC and CTRI.
Patients will be hospitalised the day before surgery and instructed to fast for 6 hours (for solids) and 4 hours (for liquids) prior to the procedure.
Inj Pantaprazole 40mg IV and Inj Metaclopramide 10mg IV will be administered 30 minutes prior to surgery.
In the OT, infusion of ringer lactate will be started. Patients will be connected to a multichannel monitor displaying electrocardiography, oxygen saturation, non invasive blood pressure and end tidal carbon dioxide. Leak pressure will also be monitored.
All the patients will be administered Inj Glycopyrrolate 0.2mg IV, Inj Midazolam 1mg IV, Inj Fentanyl 2mcg/kg IV. Preoxygenation will be done for 3 minutes. All the patients will be induced with Inj Propofol 2mg/kg IV in slow incremental dose and ease of mask ventilation will be noted.
Selection of the size of LMA supreme and I-gel will be on the bases of the weight of the patient. The SAD’s will be inserted as per manufacturer’s user booklet. Adequate ventilation will be confirmed by chest movements and EtCO2 waveforms. Time of insertion will be defined from the removal of face mask to the time where adequate ventilation was established through SAD with capnographic confirmation. Complications including airway injury, laryngospasm and sore throat will be noted.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients assessed under ASA 1 ASA2 Patients undergoing surgery under general anesthesia Weight of patients between 30kg to 100kg.
Exclusion Criteria
- •Patients who refuse to participate in the study Known or anticipated difficult airway(RODS criteria) Surgery prolonging more than 45 minutes Full stomach patients.
Outcomes
Primary Outcomes
To compare the first attempt success rate among novices between LMA supreme and I-gel in patients undergoing elective procedures under general anesthesia
Time Frame: To compare the first attempt success rate among novices between LMA supreme and I-gel in patients undergoing elective procedures under general anesthesia during induction
Secondary Outcomes
- To compare insertion time, overall success rate(intraoperative period)
- To compare oropharyngeal leak pressure(Immediately post insertion)
- To compare ease of ryles tube insertion and airway complications(During placement and within two hours postoperatively)
Investigators
Venkata Padmavathi G
Srm Medical College Hospital And Research Institute