Evaluation of safety and efficacy of Supreme LMA and I-GEL as compared to endotracheal tube in hysterolaparoscopic surgeries under general anaesthesia: An Interventional study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- To determine change in oropharyngeal leak pressure
Study Overview
Brief Summary
This interventional study aims to evaluate and compare the safety and efficacy of two supraglottic airway devices — LMA Supreme and i-gel — with the conventional endotracheal tube (ETT) in patients undergoing hysterolaparoscopic surgeries under general anaesthesia. The study will assess parameters including ease of insertion, hemodynamic stability, oxygenation and ventilation efficacy, airway complications, and postoperative outcomes. A total of 66 patients will be randomized into three groups to receive either the LMA Supreme, i-gel, or ETT during surgery. All patients will be monitored intraoperatively and postoperatively for airway-related complications, insertion time, oropharyngeal leak pressure, and other relevant clinical indicators.
The findings of this study will help determine whether these less invasive airway devices can serve as safe and effective alternatives to endotracheal intubation in laparoscopic gynecological procedures.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •18-60 years female with ASA Grade I,II and III undergoing elective hysterolaparoscopic surgical procedure under general anaesthesia with expected duration of surgery less than 2 hours.
Exclusion Criteria
- •Patient refusal BMI more than 35 kg/m² Mallampati class 3 & 4 Inter incisor distance less than 20mm Thyromental distance less than 65mm Oropharyngeal pathology Restricted neck mobility or any cervical spine pathology History of gastro esophageal reflux disease, hiatus hernia Obstructive sleep apnea.
Outcomes
Primary Outcomes
To determine change in oropharyngeal leak pressure
Time Frame: Oropharyngeal leak pressure will be determined after securing the airway | Inspired tidal volume, expired tidal volume and peak airway pressure will be recorded at 1 minute, 3 minutes, 5 minutes, 10 minutes and there after every 20 minutes and 30 minutes.
To evaluate ventilator parameters post insertion
Time Frame: Oropharyngeal leak pressure will be determined after securing the airway | Inspired tidal volume, expired tidal volume and peak airway pressure will be recorded at 1 minute, 3 minutes, 5 minutes, 10 minutes and there after every 20 minutes and 30 minutes.
Secondary Outcomes
- To record hemodynamic responses.(To assess ease of insertion and time to establish effective ventilation)
Investigators
Dr Ogirala Keerthana
Pt JNM medical college